2012 ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVS …harmonized, standardized deﬁnitions of key data elements 3. To facilitate the further development of clinical registries, quality and

Journal of the American College of Cardiology Vol. 59, No. 3, 2012© 2012 by the American College of Cardiology Foundation and the American Heart Association, Inc. ISSN 0735-1097/$36.00

DATA STANDARDS

2012 ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVSKey Data Elements and Definitions forPeripheral Atherosclerotic Vascular DiseaseA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards(Writing Committee to Develop Clinical Data Standards forPeripheral Atherosclerotic Vascular Disease)

Developed in Collaboration With the American Association of Cardiovascular and PulmonaryRehabilitation, American Academy of Neurology, American Association of Neurological Surgeons,

American Diabetes Association, Society of Atherosclerosis Imaging and Prevention,Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance,

and Vascular Disease Foundation

WRITING COMMITTEE MEMBERSMark A. Creager, MD, FACC, FAHA, Chair; Michael Belkin, MD*; Edward I. Bluth, MD, FACR†;

Donald E. Casey, JR, MD, MPH, FAHA, FACP‡; Seemant Chaturvedi, MD, FAHA, FAAN§;Michael D. Dake, MD; Jerome L. Fleg, MD, FACC, FAHA�; Alan T. Hirsch, MD, FACC, FAHA;

Michael R. Jaff, DO, FACC¶; John A. Kern, MD#; David J. Malenka, MD, FACC, FAHA**;Edward T. Martin, MD, FACC, FACP, FAHA††; Emile R. Mohler, III, MD, FACC, FAHA‡‡;Timothy Murphy, MD, FACR, FAHA, FSIR, FSVMB§§; Jeffrey W. Olin, DO, FACC, FAHA;

Judith G. Regensteiner, PHD, FAHA��; Robert H. Rosenwasser, MD, FACS, FAHA¶¶;Peter Sheehan, MD##; Kerry J. Stewart, EdD, MAACVPR, FAHA***;

Diane Treat-Jacobson, PHD, RN, FAHA†††; Gilbert R. Upchurch, JR, MD, FACS, FAHA*;Christopher J. White, MD, FACC, FAHA‡‡‡; Jack A. Ziffer, MD, PHD, FACC, FAHA, FSCCT§§§

*Society for Vascular Surgery Representative. †American College of Radiology Representative. ‡American College of Physicians Representative.§American Academy of Neurology Representative. �National Heart, Lung, and Blood Institute Representative. The findings and conclusions in this reportare those of the author(s) and do not necessarily represent the official positions of the National Heart, Lung, and Blood Institute. ¶Vascular DiseaseFoundation Representative. #Society of Thoracic Surgeons Representative. **ACCF/AHA Task Force on Data Standards Liaison to the WritingCommittee. ††Society for Cardiovascular Magnetic Resonance Representative. ‡‡Society of Atherosclerosis Imaging and Prevention Representative.§§Society of Interventional Radiology Representative. � �Society for Vascular Medicine Representative. ¶¶American Association of NeurologicalSurgeons Representative. ##American Diabetes Association Representative. ***American Association of Cardiovascular and Pulmonary RehabilitationRepresentative. †††Society for Vascular Nursing Representative. ‡‡‡Society for Cardiovascular Angiography and Interventions Representative.§§§Society of Cardiovascular Computed Tomography Representative. � � �Immediate Past Chair of the ACCF/AHA Task Force on Clinical DataStandards.

This document was approved by the American College of Cardiology Foundation Board of Trustees and the American Heart Association ScienceAdvisory and Coordinating Committee in June 2011; the Society of Interventional Radiology, Society of Thoracic Surgeons, Society for VascularMedicine, and Society for Vascular Nursing in October 2011; the American College of Radiology and Society for Cardiovascular Angiography andInterventions in November 2011; and the Society for Vascular Surgery in December 2011.

The American College of Cardiology Foundation requests that this document be cited as follows: Creager MA, Belkin M, Bluth EI, Casey DE Jr,Chaturvedi S, Dake MD, Fleg JL, Hirsch AT, Jaff MR, Kern JA, Malenka DJ, Martin ET, Mohler ER 3rd, Murphy T, Olin JW, Regensteiner JG,Rosenwasser RH, Sheehan P, Stewart KJ, Treat-Jacobson D, Upchurch GR Jr, White CJ, Ziffer JA. 2012 ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVS key data elements and definitions for peripheral atherosclerotic vascular disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Clinical Data Standards for PeripheralAtherosclerotic Vascular Disease). J Am Coll Cardiol 2012;59:294–357.

This article is copublished in Circulation.Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.cardiosource.org) and the American

Heart Association (my.americanheart.org). For copies of this document, please contact Elsevier Inc. Reprint Department, fax (212) 633-3820, [email protected].

Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express

Published by Elsevier Inc. doi:10.1016/j.jacc.2011.10.860

permission of the American College of Cardiology Foundation. Please contact Elsevier’s permission department at [email protected].

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295JACC Vol. 59, No. 3, 2012 Creager et al.January 17, 2012:294–357 ACCF/AHA PAVD Data Standards

ACCF/AHA TASK FORCE ON CLINICAL DATA STANDARDSRobert C. Hendel, MD, FACC, FAHA, Chair; Biykem Bozkurt, MD, PHD, FACC, FAHA;

Gregg C. Fonarow, MD, FACC, FAHA; Jeffrey P. Jacobs, MD, FACC;Pamela N. Peterson, MD, FACC; Véronique L. Roger, MD, MPH, FACC, FAHA��;

Eric E. Smith, MD, MPH, FAHA; James E. Tcheng, MD, FACC, FSCAI;Tracy Wang, MD, FACC, FAHA; William S. Weintraub, MD, FACC, FAHA

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TABLE OF CONTENTS

reamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .295

. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .296

. Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .297

2.1. Writing Committee Composition. . . . . . . . . . . . . .2972.2. Relationships With Industry and

Other Entities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2972.3. Review of Literature and Existing Data

Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2972.4. Defining Data Elements . . . . . . . . . . . . . . . . . . . . . .2972.5. Relation to Other Standards . . . . . . . . . . . . . . . . .2972.6. Consensus Development. . . . . . . . . . . . . . . . . . . . .2972.7. Peer Review, Public Review, and

Board Approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3042.8. Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .304

. PAVD Data Standard Elements and Definitions . . .304

3.1. General Table of Data Elements . . . . . . . . . . . . . .3043.2. Lower Extremity PAD Table of Data Elements. . .3163.3. AAA Table of Data Elements . . . . . . . . . . . . . . . . .3273.4. Renal and Mesenteric Artery Disease

Table of Data Elements . . . . . . . . . . . . . . . . . . . . . .3273.5. Extracranial Carotid and Vertebral Artery

Disease Table of Data Elements. . . . . . . . . . . . . .340

eferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .352

ppendix 1: Author Relationships With Industrynd Other Entities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .354

ppendix 2: Peer Reviewer Relationships Withdustry and Other Entities . . . . . . . . . . . . . . . . . . . . . . .356

reamble

he American College of Cardiology Foundation (ACCF)d the American Heart Association (AHA) support theirembers’ goal to improve the prevention and care ofrdiovascular diseases through professional education,search, and development of guidelines and standards andfostering policy that supports optimal patient outcomes.

he ACCF and AHA recognize the importance of the useclinical data standards for patient management, to assesstcomes, and conduct research and the importance of
fining the processes and outcomes of clinical care, co
hether in randomized trials, observational studies, regis-ies, or quality improvement initiatives.Hence, clinical data standards strive to define and standard-

e data relevant to clinical topics in cardiology, with theimary goal of assisting data collection by providing aatform of data elements and definitions applicable torious conditions. Broad agreement on a common vocabu-ry with reliable definitions used by all is vital to pool and/ormpare data across studies to promote interoperability ofectronic health records and to assess the applicability ofsearch to clinical practice. The increasing national focus onoption of certified electronic health records along with

nancial incentives for providers to demonstrate “meaningfule” of those electronic health records to improve healthcareality render even more imperative and urgent the need forch definitions and standards. Therefore, the ACCF andHA have undertaken to define and disseminate clinical dataandards: sets of standardized data elements and correspond-g definitions to collect data relevant to cardiovascularnditions. The ultimate purpose of clinical data standards iscontribute to the infrastructure necessary to accomplish the

CCF/AHA’s missions of fostering optimal cardiovascularre and disease prevention and building healthier lives, freecardiovascular diseases and stroke, respectively.The specific goals of clinical data standards areTo establish a consistent, interoperable, and universalclinical vocabulary as a foundation to both clinical careand clinical researchTo promote the ubiquitous use of electronic health recordsand facilitate the exchange of data across systems throughharmonized, standardized definitions of key data elementsTo facilitate the further development of clinical registries,quality and performance improvement programs, out-comes evaluations, and clinical research, including thecomparison of results within and across these initiatives

he key elements and definitions are a compilation ofriables intended to facilitate the consistent, accurate, andproducible capture of clinical concepts; standardize therminology used to describe cardiovascular diseases andocedures; create a data environment conducive to thesessment of patient management and outcomes for qualityd performance improvement and for clinical and transla-

onal research; and increase opportunities for sharing dataross disparate data sources. The ACCF/AHA Task Force onlinical Data Standards selects cardiovascular conditions andocedures that will benefit from creating a data standard set.xperts in the subject are selected to examine/consideristing standards and develop a comprehensive, yet nothaustive, data standard set. When undertaking a data
llection effort, only a subset of the elements contained in a

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296 Creager et al. JACC Vol. 59, No. 3, 2012ACCF/AHA PAVD Data Standards January 17, 2012:294–357

inical data standards listing may be needed, or, conversely,ers may want to consider whether it may be necessary tollect some elements not listed. For example, in the settinga randomized clinical trial of a new drug, additional

formation regarding study procedures and drug therapiesould likely be required.The ACCF and AHA recognize that there are othertional efforts to establish clinical data standards, and everytempt is made to harmonize newly published standards withisting standards. Writing committees are instructed tonsider adopting or adapting existing nationally recognizedta standards if the definitions and characteristics are usefuld applicable to the set under development. In addition, theCCF and AHA are committed to continually expandingeir portfolio of data standards and will create new standardsd update existing standards as needed to maintain theirrrency and promote harmonization with other standards asalth information technology and clinical practice evolve.The Health Insurance Portability and Accountability ActIPAA) privacy regulations, which went into effect in April03, have heightened all practitioners’ awareness of ourofessional commitment to safeguard patients’ privacy. TheIPAA privacy regulations (1) specify which informationements are considered “protected health information.”hese elements may not be disclosed to third parties (includ-g registries and research studies) without the patient’sritten permission. Protected health information may becluded in databases used for healthcare operations under ata use agreement. Research studies using protected healthformation must be reviewed by an institutional revieward or a privacy board.We have included identifying information in all clinicalta standards to facilitate uniform collection of these ele-ents when appropriate. For example, a longitudinal clinictabase may contain these elements, because access isstricted to the patient’s caregivers. On the other hand,gistries may not contain protected health information unlessecific permission is granted by each patient. These fieldse indicated as protected health information in the dataandards.The ACCF/AHA Task Force on Clinical Data Standardsakes every effort to avoid any actual or potential conflicts ofterest that may arise as a result of an outside relationship orpersonal, professional, or business interest of a member ofe writing panel. Specifically, all members of the writingoup were required to submit a disclosure form showing allch relationships that might be perceived as real or potentialnflicts of interest. These statements are reviewed by theCCF/AHA Task Force on Clinical Data Standards, reportedally to all members of the writing panel at the first meeting,d updated as changes occur. Writing committee members’lationships with industry or other entities (RWI) are listedAppendix 1. Official peer reviewers’ RWI are listed in

ppendix 2.In clinical care, caregivers communicate with each otherrough a common vocabulary. In an analogous fashion, thetegrity of clinical research depends on firm adherence to
especified procedures for patient enrollment and follow-up; ou
ese procedures are guaranteed through careful attention tofinitions enumerated in the study design and case reportrms. When data elements and definitions are standardizedross studies, comparisons, pooled analysis, and meta-alysis are enabled, thus deepening our understanding ofdividual studies.The recent development of quality performance measure-ent initiatives, particularly those for which comparison ofoviders is an implicit or explicit aim, has further raisedareness about the importance of data standards. Indeed, a

ide audience, including nonmedical professionals such asyers, regulators, and consumers, may draw conclusionsout care and outcomes. To understand and compare caretterns and outcomes, the data elements that characterizeem must be clearly defined, consistently used, and properlyterpreted, now more than ever before.

Robert C. Hendel, MD, FACC, FASNC, FAHAhair, ACCF/AHA Task Force on Clinical Data Standards

. Introduction

therosclerotic vascular disease refers to disorders of theteries caused by atherosclerosis (2). This document pro-des data standards for peripheral atherosclerotic vascularseases (PAVDs), including lower extremity peripheral ar-ry disease (PAD), abdominal aortic aneurysm (AAA), renald mesenteric artery disease, and extracranial carotid arterysease. It may serve as a companion to the “2005 ACC/AHAuidelines for the Management of Patients With Peripheralrterial Disease” (3), the “2011 ACCF/AHA Focused Update

the Guideline for the Management of Patients Witheripheral Artery Disease” (4), and the “2010 ACCF/AHAerformance Measures for Adults With Peripheral Arteryisease” (5). Coronary artery disease is outside the scope ofis document. Multiple disciplines are engaged in the eval-tion and management of patients with PAVDs, and devel-ments in relevant research and technology are emergingpidly. Therefore, to ensure optimal documentation andmmunication among healthcare providers, researchers, pol-y makers, payers, and industry, the establishment of aiform set of data elements and definitions for PAVDs couldt be more timely and compelling.The data standards covered in this document are dividedto 6 distinct tables. The first table covers general dataements common to all PAVDs, including demographicformation, atherosclerotic risk factors, concurrent athero-lerotic diseases, comorbid conditions, medications, therdiovascular examination, and relevant blood chemistriesd hematology. The remaining tables cover data standardsecific for lower extremity PAD, AAA, renal artery disease,esenteric artery disease, and extracranial carotid and verte-al artery disease, respectively. Each of the disease-specificbles includes the following data elements: medical history,ysical examination, laboratory testing, diagnostic proce-res, invasive therapeutic procedures (both endovasculard open surgical), pharmacological therapy, follow-up, and
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. Methodology

.1. Writing Committee Compositionhe ACCF/AHA Task Force on Clinical Data Standardslected members for the Writing Committee to Developlinical Data Standards for Peripheral Atherosclerotic Vas-lar Disease. The writing committee consisted of 23 mem-rs who are well versed in the epidemiology, clinicalaluation, medical management, invasive therapy, and/ortcomes assessment of patients with vascular disease andcluded members with expertise in patient care, clinicalvestigation, and healthcare services research and delivery.he writing committee included representatives from a broadnge of cardiovascular professional societies and organiza-ons to ensure that the content of this document is widelyplicable. All partnering and collaborating organizationsminated people to serve on the writing committee.

.2. Relationships With Industry andther Entitieshe ACCF/AHA Task Force on Clinical Data Standardsakes every effort to avoid any actual, potential, orrceived conflicts of interest that may arise as a result of

WI among members of the writing committee. Specifi-lly, all members of the writing group, as well as peerviewers of the document, were required to disclose allrrent relationships and those that existed 24 monthsfore initiation of this writing effort that might berceived as relevant. These statements were reviewed bye ACCF/AHA Task Force on Clinical Data Standardsd by all members during each conference call or meeting

the writing committee and updated when changescurred. This writing effort was initiated before theplementation of the updated ACCF and AHA policy on

WI, which requires that the writing committee chair plusmajority of the writing committee have no relevant RWI.elevant RWI disclosed by writing committee membersd peer reviewers are listed in Appendixes 1 and 2,spectively. Comprehensive disclosure information fore Task Force is available online at available online at www.rdiosource.org/ACC/About-ACC/Leadership/Guidelines-and-ocuments-Task-Forces.aspx. The work of the writing com-ittee was supported exclusively by the ACCF and AHAnd the other partnering organizations) without commercialpport. Writing committee members volunteered their timer this effort. Meetings of the writing committee werenfidential and attended only by committee members and

aff.

.3. Review of Literature andxisting Data Definitionshe nomenclature used in this document to designate specificAVDs, including lower extremity PAD, AAA, renal andesenteric artery disease, and extracranial carotid arterysease, is derived from an AHA conference proceeding (2).
he “Peripheral Atherosclerotic Vascular Disease Data Stan- pe
rds” are intended to provide data elements that parallel andmplement existing data fields previously reported in ACCFd AHA data standards documents (6–11), along with thoseed as fields within existing registries, such as those devel-ed by the ACC National Cardiovascular Disease Registry2). The writing committee also reviewed the “2007 ACC/HA Methodology for the Development of Clinical Datatandards” (13), the reporting standards formulated by theociety for Vascular Surgery/International Society for Car-ovascular Surgery; the “AHA Guidelines for the ReportingRenal Artery Revascularization in Clinical Trials” (14); the

ational Heart, Lung, and Blood Institute CLEVER (Claudi-tion: Exercise Vs Endoluminal Revascularization) Study5,16); CORAL (Cardiovascular Outcome in Renal Athero-lerotic Lesions) trials (17,18); National Institute of Neuro-gical Disorders and Stroke Common Data Elements (19);d the AHA Get With The Guidelines–Stroke Program (20).

.4. Defining Data Elementshe definitions of the data elements developed by the writingmmittee are broad enough for use in various aspects of datallection but specific enough to promote uniform and sim-ified interpretation of data. Some elements will require anditional level of specificity by the end user for implemen-tion, which is beyond the scope of this document. Datafinitions were linked whenever possible to the evidence-sed national guidelines.To ensure consistency across ACCF/AHA data standards,e writers used existing ACCF/AHA definitions. The writingmmittee chose not to develop an all-inclusive list of everyssible data element that may be used for all aspects of

AVD. Rather, the committee focused on common elementsat cross vascular specialty disciplinary boundaries. It isticipated that some data definitions and elements willed further delineation, likely by subspecialty societies andoups. The purpose of this document is to attempt tormonize as many common data fields as possible.

.5. Relation to Other Standardss previously noted, the writing committee reviewed otherandards, including those developed for heart failure, atrialbrillation, electrophysiology, acute coronary syndromes,d cardiac imaging. It was thought that members of theriting committee possessed the key levels of expertiseeded to address issues relating to PAVD in a consistentanner.

.6. Consensus Developmenthese ACCF/AHA data standards, like other documentsveloped by the ACCF and AHA, were developed andritten as a team effort based on the judgments of experts.he writing committee met �10 times, by telephone and inrson, to define and refine the data elements. Throughout theocess, consensus was developed through extensive in-
rson discussion, teleconferences, and e-mail messages.
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ement Name Definition

mographics

Sex Indicate the patient’s sex at birth. Choose 1 of the following:

● Male● Female

Date of birth Indicate the patient’s date of birth (mo/d/y).

Race Indicate the patient’s race as determined by the patient/family:

● American Indian or Alaska Native● Asian● Black or African American● Native Hawaiian or Other Pacific Islander● White● Other (specify)

Hispanic ethnicity Is the patient Spanish, Hispanic, or Latino? Choose 1 of the following:

● Yes● No

Patient zip code Indicate the zip code of the residence where the patient typically lives.

Institution Coded identification and location of the healthcare facility.

Insurance payer Indicate the patient’s primary insurance payer for this admission. Choose 1 of the following:

● Government: Refers to patients who are covered by government-reimbursed care. In the United States thisincludes— Medicare— Medicaid (including all state or federal Medicaid-type programs)— Veterans Health Administration— Department of Defense— Other federal group (specify)

● Commercial: Refers to all indemnity (fee-for-service) carriers and PPOs● HMO: Refers to a health maintenance organization characterized by coverage that provides healthcare services for

members on a prepaid basis● None: Refers to patients with limited or no health insurance; thus, the patient is the payer regardless of ability to

pay. Only mark “None” when “self” or “none” is denoted as the first insurance in the medical record.

esentation to Healthcare Facility

Presentation to healthcare facility Indicate the date and time the patient presented to the healthcare facility.

Type of encounter ● Emergency admission for stroke● Emergency admission for TIA● Emergency admission for limb ischemia● Emergency admission for other cardiovascular problem● Emergency admission for noncardiovascular problem● Planned admission for evaluation/treatment of carotid artery disease● Planned admission for evaluation/treatment of PAD● Planned admission for evaluation/treatment of aortic aneurysm● Planned admission for evaluation/treatment of renal/mesenteric artery disease● Planned admission for other cardiovascular problem● Planned admission for noncardiovascular problem● Regularly scheduled outpatient visit● Urgent or other unscheduled outpatient visit

Primary reason for encounter ● Symptoms related to carotid artery disease● Symptoms related to PAD● Symptoms related to aortic aneurysmal disease● Symptoms related to renal artery disease● Symptoms related to mesenteric artery disease● Symptoms related to other cardiovascular disease● Noncardiovascular symptoms

Admission location ● ICU/stroke unit● Step-down unit● Unmonitored hospital floor● Observation/holding unit in emergency department● Outpatient

(Continued)

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Means of transport ● Self/family/friend/caregiver● Taxi/public transportation● Ambulance● Mobile ICU● Air or ambulance transfer from another facility

Location of encounter (21) Indicate the location of encounter:● Air or ambulance transfer from another facility● Caregiver office: primary care or specialist● Urgent care facility● Inpatient hospital● Outpatient hospital● Emergency department● Ambulatory surgery center● Inpatient rehabilitation facility● SNF● Mobile unit

tient History

Risk Factors for Atherosclerosis

Hypertension Indicate if the patient has a current or previous diagnosis of hypertension as defined by any of the following:● History of hypertension diagnosed and treated with medication, diet, and/or exercise● On at least 2 occasions, documented blood pressure �140 mm Hg systolic and/or 90 mm Hg diastolic in patients

without diabetes or chronic kidney disease; �130 mm Hg systolic or 80 mm Hg diastolic in patients withdiabetes or chronic kidney disease

● Currently on pharmacological therapy for treatment of hypertension

More than 1 of the above may apply. The year of onset (first diagnosis) may be helpful.

Diabetes (22) History of diabetes diagnosed and/or treated by a physician. The American Diabetes Association criteria includedocumentation of the following:● Hemoglobin A1c �6.5%; or● Fasting plasma glucose �126 mg/dL (7.0 mmol/L); or● Two-hour plasma glucose �200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; or● In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose

�200 mg/dL (11.1 mmol/L).

This does not include gestational diabetes.

Indicate the following:

1. Type 1 or type 2 diabetes

2. Year of onset (if known)

Dyslipidemia Current or previous diagnosis of dyslipidemia per the National Cholesterol Education Program criteria (23), defined asany 1 of the following:● Total cholesterol �200 mg/dL (5.18 mmol/L)● LDL �130 mg/dL (3.37 mmol/L)● HDL �40 mg/dL (1.04 mmol/L) in men and �50 mg/dL (1.30 mmol/L) in women

Treatment is also initiated if LDL is �100 mg/dL (2.59 mmol/L) in patients with known coronary artery disease orCHD equivalent, and this would qualify as hypercholesterolemia.

History of smoking (24) History confirming cigarette smoking in the past. Choose from the following categories:● Current every day smoker● Current some days smoker● Former smoker● Never smoker● Smoker, current status unknown● Unknown if ever smoked

For current or former smokers, total pack years may be useful.

Alcohol consumption Specify the patient’s history of alcohol consumption. Choose from the following categories:● None● �1 alcoholic drinks/wk● 2–7 alcoholic drinks/wk● 8–13 alcoholic drinks/wk● 14–20 alcoholic drinks/wk● �21 alcoholic drinks/wk

(Continued)

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Specify alcohol-dependency history. Choose all that apply:

Documented alcohol dependency

Medical sequelae of alcohol consumption (alcoholic hepatitis, cirrhosis, alcohol neuropathy,Wernicke-Korsakoff syndrome)

Treatment for alcohol dependency

For patients with alcohol dependency, note treatment for dependency, cessation of use, or continued use.

Illicit drug use Indicate history of current, recent, or remote abuse of any illicit drug (e.g., cocaine, methamphetamine, marijuana)or controlled substance. Choose 1 of the following:● Yes● No

Evidence of Atherosclerosis

History of MI The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical settingconsistent with myocardial ischemia. Under these conditions, any 1 of the following criteria meets the diagnosisfor MI:● Detection of rise and/or fall of cardiac biomarkers (preferably troponin) with at least 1 value above the

99th percentile of URL together with evidence of myocardial ischemia with at least 1 of the following:— Symptoms of ischemia— Electrocardiographic changes indicative of new ischemia (new ST-T changes or new LBBB)— Development of pathological Q waves in the ECG— Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality

● Sudden unexpected cardiac death, involving cardiac arrest, often with symptoms suggestive of myocardialischemia, and accompanied by presumably new ST elevation or new LBBB and/or evidence of fresh thrombus bycoronary angiography a time before the appearance of cardiac biomarkers in the blood.

● For PCI in patients with normal baseline indicative of periprocedural myocardial necrosis. By convention, increasesof biomarkers �3�99th percentile URL have been designated as PCI-related MI. A subtype related to adocumented stent thrombosis is recognized.

● For CABG in patients with normal baseline troponin values, elevations of cardiac biomarkers above the99th percentile URL are indicative of periprocedural myocardial necrosis. By convention, increases of biomarkers�5�99th percentile URL plus either new pathological Q waves or new or imaging evidence of new loss of viablemyocardium have been designated as defining CABG-related MI.

● Pathological findings of an acute MI.

MI within the past 6 wk Indicate if the patient had an MI within 6 wk prior to the index procedure as evidenced by the following:

1. Acute MI (�7 d) manifested as a rise and fall of cardiac biomarkers (preferably troponin) with at least 1 valueabove the range of normal for your laboratory (above the 99th percentile of the URL) together with evidence ofmyocardial ischemia with at least 1 of the following:

a. Ischemic symptoms

b. Electrocardiographic changes indicative of new ischemia (new ST-T and/or T-wave changes or new LBBB)

c. Development of pathological Q waves on the ECG

d. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality

2. Recent MI (�7 d) manifested by

a. An MI meeting the criteria for an acute MI as documented in the medical record, or

b. By any 1 of the following:

1. Development of new pathological Q waves with or without symptoms

2. Imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract

3. In the absence of a nonischemic cause

History of angina History of angina may include

● Stable angina— Indicate CCS class

● Unstable angina● Prior angina; currently asymptom1atic

Dates should be sought for the onset of either stable or unstable angina.

Previous CABG surgery Indicate history of prior CABG surgery, including the date or year of surgery.

The total number of CABG procedures and the year of the most recent procedure may be helpful.

Previous PCI Prior PCI of any type (balloon angioplasty, atherectomy, stent, or other)Total number of PCI procedures and dates(years)

(Continued)

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History of PAD Indicate if the patient has a history of lower extremity PAD (from iliac to tibials). Excludes renal, coronary, cerebral,and mesenteric vessels and aneurysm. Major symptoms can include● Asymptomatic (confirmed by noninvasive diagnostic test)● Claudication relieved by rest● Ischemic rest pain● Tissue loss (including ischemic ulcer and/or gangrene)● Amputation for critical limb ischemia● Vascular reconstruction, bypass surgery, or percutaneous revascularization in the arteries of the lower extremities● Positive noninvasive test (e.g., ABI �0.90, ultrasound, MR or CT imaging demonstrating �50% diameter stenosis

in any peripheral artery, ie, aorta, iliac, femoral, popliteal, tibial, peroneal)

History of aortic aneurysm Indicate if the patient has a history of aortic aneurysm. This can include● Thoracic aneurysm● Thoracoabdominal aneurysm● AAA

Confirmed by ultrasound, CT, and/or MR imaging.

History of renal ormesenteric artery disease

Indicate if the patient has a history of renal or mesenteric artery disease. This can include an abnormal imagingstudy such as duplex ultrasonography, MRA, CTA, or catheter-based contrast angiography demonstrating �50%diameter stenosis in the renal artery, celiac trunk, SMA, or IMA.

TIA (25) Indicate if the patient has a documented history of TIA consisting of a transient episode of neurological dysfunctioncaused by focal brain, spinal cord, or retinal ischemia without acute infarction.

Note the following:● Right retinal● Right hemispheric● Left retinal● Left hemispheric● Vertebrobasilar● Unknown distribution

Prior stroke Indicate whether the patient has a history of stroke, which is defined as an acute episode of neurological dysfunctioncaused by focal or global brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.

If present, record the type of stroke (26,27):● Ischemic● Intracerebral hemorrhage● Subarachnoid hemorrhage● Unknown

If ischemic, list the most likely etiologies:● Large-artery atherosclerosis of the extracranial vessels (e.g., carotid)● Large-artery atherosclerosis of the intracranial vessels (e.g., middle cerebral artery stenosis)● Cardioembolism● Small-vessel occlusion (lacunar)● Ischemic stroke of other determined etiology (e.g., arterial dissection)● Ischemic stroke of undetermined etiology

Congestive Heart Failure

CHF Indicate if the patient has a previous history of CHF. This includes a previous hospital admission with a principaldiagnosis of CHF.

CHF is defined as documentation or report of any 2 of the following Framingham major criteria of heart failure:orthopnea/paroxysmal nocturnal dyspnea; or the description of rales, jugular venous distention, hepatojugular reflux,S3 gallop, or pulmonary edema on chest x-ray; or 1 of the major criteria plus 2 Framingham minor criteria, includingdyspnea on exertion, nocturnal cough, ankle edema, pleural effusion, or tachycardia. A low ejection fraction withoutclinical evidence of heart failure does not qualify as heart failure.

Include the year of onset if known.

NYHA classification scale (28) To classify symptoms or signs in patients with suspected or presumed heart failure per the NYHA classificationscale:● Class I: without limitations of physical activity. Ordinary physical activity does not cause undue fatigue,

palpitations, or dyspnea.● Class II: slight limitation of physical activity. The patient is comfortable at rest. Ordinary physical activity results in

fatigue, palpitations, or dyspnea.● Class III: marked limitation of physical activity. The patient is comfortable at rest. Less than ordinary activity

causes fatigue, palpitations, or dyspnea.● Class IV: inability to carry on any physical activity without discomfort. Heart failure symptoms are present even at

rest or with minimal exertion.

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Pulmonary insufficiency Indicate if the patient has a history of pulmonary insufficiency. Pulmonary insufficiency is defined as Pao2 of�60 mm Hg while breathing air or Paco2 of �50 mm Hg.

Chronic kidney disease (29) Current or previous history of chronic kidney disease. Chronic kidney disease is defined as either kidney damage orGFR �60 mL/min/1.73 m2 for �3 mo. Kidney damage is defined as pathologic abnormalities or markers of damage,including abnormalities in blood or urine tests or imaging studies.

Indicate the patient’s stage of disease:● Stage 0: No known kidney disease● Stage 1: Kidney damage with normal or high GFR �90 mL/min/1.73 m2

● Stage 2: Kidney damage with mildly decreased GFR—60–89 mL/min/1.73 m2

● Stage 3: Moderately decreased GFR—30–59 mL/min/1.73 m2

● Stage 4: Severely decreased GFR—15–29 mL/min/1.73 m2

● Stage 5: Kidney failure—GFR �15 mL/min/1.73 m2 or on dialysis

Note: GFR may be estimated using the serum creatinine MDRD formula:

eGFR�186 (serum creatinine)�1.154 (age)�0.203 (0.742 [if female]) (1.210 [if black])

Year of onset (first diagnosis) may be helpful.

tient Assessment:ysical Evaluation

Height Patient’s height in centimeters. To be converted from conventional units if needed

Note: May be measured or reported by the patient.

Weight Patient’s measured actual weight in kilograms. To be converted from conventional units if needed

Note: Must be measured during encounter. It is advisable to standardize clothing worn (i.e., whether shoes are worn).

BMI BMI is calculated according to the following formula: the patient’s weight in kilograms, divided by height in meterssquared. Obesity is defined as a BMI �30 kg/m2.

Blood pressure (right and left arm) Systolic and diastolic blood pressure (mm Hg) in both the right and left arms recorded closest to the time ofpresentation at the healthcare facility. The patient’s position (supine, sitting, other) may be noted.

Heart rate Number of heart beats over 1 min.

Note: Recorded closest to the time of presentation at the healthcare facility and/or on discharge (for inpatient).

Specify whether the heart rate is regular or irregular. Heart rate may be ascertained from the ECG or record ofphysical examination.

Cardiac rhythm Indicate if the patient has any of the following:● Normal sinus rhythm● Atrial fibrillation● Other

Complete vascular examination Carotid, upper, lower extremity pulses, auscultation of the neck for carotid bruits, auscultation of the abdomen andfemoral arteries for bruits, palpation of the abdomen and popliteal fossa for aneurysms

Complete cardiac examination Palpation and auscultation of the heart, assessing rate, rhythm, presence of murmur, presence of gallop (e.g., S3

suggesting left ventricular dysfunction; S4 suggesting noncompliant left ventricle), notation of location of point ofmaximal intensity

Limb edema Note the presence/absence of lower extremity (less commonly, upper extremity) edema, including location, extent,and pitting versus nonpitting.

boratory Testing

CBC Include RBC, WBC, and platelet counts: 1) value, 2) unit of measurement, 3) date, and 4) normal range(upper limit of normal when appropriate)

Hemoglobin 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Hematocrit 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Glucose 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

BUN 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Creatinine 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

GFR Indicate estimated or actual GFR in milliliters per minute per 1.73 meters squared.

Sodium 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper and lower limit of normal when appropriate)

Potassium 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper and lower limit of normal when appropriate)

Hemoglobin A1C 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Prothrombin time Measured in seconds. Report INR as ratio.

Partial thromboplastin time Indicate whether activators used (aPTT) or not (PTT). Measured in seconds.

Total cholesterol 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

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LDL 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

HDL 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Triglycerides 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

hs-CRP 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

ESR 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Calcium 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper and lower limit of normal when appropriate)

Phosphorus 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper and lower limit of normal when appropriate)

Magnesium 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper and lower limit of normal when appropriate)

TSH 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

BNP or N-terminal BNP 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

AST 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

ALT 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

CK The upper limit of normal of total CK as defined by individual hospital laboratory standards. Units of CK and type ofunits should be noted (e.g., IU, ng/dL, kCat/L).

All CK values during hospitalization should be noted; include units, date, and time.

Troponin Indicate which type: T or I.

Indicate the upper limit of normal (usually the 99th percentile of a normal population) and units (e.g., ng/dL).

All troponin T or I values during hospitalization should be noted; include units, date, and time.

Homocysteine 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Vitamin B12 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Folate 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Prothrombin 20210 gene mutation 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Protein C activity 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Protein S activity 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Antithrombin III 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Anticardiolipin antibody 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

Lupus anticoagulant 1) value, 2) unit of measurement, 3) date, and 4) normal range (upper limit of normal when appropriate)

rrent Pharmacologic Therapy toanage Cardiovascular Disease

Antiplatelet Drugs

Aspirin Note specific dose.

Clopidogrel Note specific dose.

Prasugrel Note specific dose.

Other P2Y12 antagonists Note specific drug and dose.

Dipyridamole Note specific dose.

Others Note specific drug and dose.

Anticoagulant Drugs

Unfractionated heparin Note specific dose.

Low–molecular-weight heparin Note specific drug and dose.

Fondaparinux Note specific dose.

Other factor Xa inhibitor Note specific drug and dose.

Direct thrombin inhibitor Note specific drug and dose.

Warfarin Indicate whether this drug has been prescribed; note INR.

Others Note specific drug and dose.

Drugs to ControlCardiovascular Risk Factors

Antihypertensive drugs Note specific drug and dose.

Statins and lipid-control agents Note specific drug and dose.

Drugs for diabetes Note specific drug and dose.

Drugs to aid insmoking cessation

Note specific drug and dose.

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.7. Peer Review, Public Review, andoard Approvalhis set of standards and definitions for PAVD was indepen-ntly reviewed by official appointees from the ACCF, AHA,merican College of Radiology, Society for Cardiovascularngiography and Interventions, Society of Interventional Radi-ogy, Society for Vascular Medicine, Society for Vascularursing, Society for Vascular Surgery, and the ACCF/AHAask Force on Clinical Data Standards, as well as experts fromllaborating organizations, namely, the American College of

hysicians; American Association of Cardiovascular and Pul-onary Rehabilitation; American Academy of Neurology;merican Diabetes Association; National Heart, Lung, andlood Institute; Society of Atherosclerosis Imaging and Preven-n; Society of Cardiovascular Computed Tomography; Societyr Cardiovascular Magnetic Resonance; and Vascular Disease

oundation. To increase its applicability, this document wassted on the ACC Web site for a 30-day public commentriod from September 1, 2010, through October 1, 2010. Thecument was then approved by the ACCF Board of Trusteesd the AHA Science Advisory and Coordinating Committee inne 2011; American Association of Cardiovascular and Pulmo-ry Rehabilitation, American Academy of Neurology, Ameri-n Diabetes Association, Society of Atherosclerosis Imagingd Prevention, Society of Cardiovascular Computed Tomogra-y, Society for Cardiovascular Magnetic Resonance, Society ofterventional Radiology, Society of Thoracic Surgeons, Societyr Vascular Medicine, Society for Vascular Nursing, andascular Disease Foundation in October 2011; the Americanollege of Radiology and Society for Cardiovascular Angiog-phy and Interventions in November 2011; and the Society forascular Surgery in December 2011.The writing committee anticipates that these data standards

ill require review and updating, as with the ACCF/AHAidelines, performance measures, and appropriate use crite-

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Drugs for CoexistingCardiovascular Conditions

Antiarrhythmic drugs Note specific drug and dose.

Heart failure medications Note specific drug and dose.

Drugs for symptoms of PAD Note specific drug and dose.

Noncardiovascular medications Note the specific drug and dose.

her Elements Related toarmacological Therapy toanage Cardiovascular Disease

Medication allergy Specify the medication and type of

Medication side effect Describe the side effect and wheth

AAA indicates abdominal aortic aneurysm; ABI, ankle brachial index; ALT, alainotransferase; BMI, body mass index; BNP, B-type natriuretic peptide; BUN, bS, Canadian Cardiovascular Society; CHD, coronary heart disease; CHF,

ectrocardiogram; ESR, erythrocyte sedimentation rate; GFR, glomerular filtrationgh-sensitivity C-reactive protein; ICU, intensive care unit; IMA, inferior mesentw-density lipoprotein; MDRD, modification of diet in renal disease; MI, myocardiw York Heart Association; PAD, peripheral artery disease; PCI, percutaneous coe; RBC, red blood cell; SMA, superior mesenteric artery; SNF, skilled nursing

ference limit; and WBC, white blood cell.

a. At the anniversary of publication, the writing committee su

ill review the data standards to ascertain whether modifica-ons should be considered.

.8. Intended Usehe writing committee anticipates that the “Key Data Ele-ents and Definitions for Peripheral Atherosclerotic Vascularisease” will prove useful in several settings:

Clinical programs in which providers and health planswork in concert to achieve optimal use of procedurespertinent to PAVD. Data standards will assist in thedevelopment of structured reporting systems and theorganization and design of electronic medical informationsystems, including clinical database and decision supporttools.Clinical research, including prospective registries andrandomized controlled trials. Meta-analyses will be par-ticularly strengthened by the use of standardized data forkey variables.Quality assessment/performance measurement. Data stan-dards will especially facilitate interpretation for nonmed-ical users, including payers, regulators, and consumers.

. PAVD Data Standard Elementsnd Definitions

.1. General Table of Data Elementshe general elements listed in Table 1 are applicable to all ofe PAVDs included in this document. These include demo-aphic elements, such as sex, age, race, ethnicity, and payerformation; elements related to the patient’s presentation,ch as the primary reason for the encounter and its location;

sk factors for atherosclerosis, such as hypertension, dyslip-emia, diabetes mellitus, and cigarette smoking; and evi-nce of previously established atherosclerotic conditions,

.

edication was stopped.

inotransferase; aPTT, activated partial thromboplastin time; AST, aspartateea nitrogen; CABG, coronary artery bypass graft; CBC, complete blood count;ive heart failure; CK, creatine kinase; CT, computed tomography; ECG,DL, high-density lipoprotein; HMO, health maintenance organization; hs-CRP,ry; INR, international normalized ratio; LBBB, left bundle-branch block; LDL,tion; MR, magnetic resonance; MRA, magnetic resonance angiography; NYHA,ntervention; PPO, preferred provider organization; PTT, partial thromboplastinTIA, transient ischemic attack; TSH, thyroid stimulating hormone; URL, upper

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tient Assessment: Signs and Symptoms

Asymptomatic The patient has no symptoms of claudication, no symptoms of ischemic pain, and no limitation in walking distance.

Claudication: characteristics Indicate claudication as determined by the discomfort:● Exertional● Reproducible● Resolves within 10 min of rest

Claudication: description Describe the discomfort. Choose all that apply:● Cramping● Aching● Fatigue● Other

Claudication: location Indicate the limb (right leg, left leg, both) with discomfort and the location of the discomfort. Choose all that apply:● Buttock● Hip● Thigh● Calf● Foot

Claudication: walking When describing walking, indicate the following:● Pain-free walking distance (ft/m/blocks)● Maximum walking distance (ft/m/blocks)● Typical walking speed

— Slow— Normal— Fast

● Flat surface versus incline

Claudication: onset of symptoms Indicate the following:● Date of onset● Duration of symptoms

Claudication: stability of symptoms Indicate if symptoms

● Improved● Stabilized● Worsened

Atypical symptoms Describe the characteristics of atypical symptoms.

Ischemic rest pain Indicate if the pain and discomfort

● Are characterized by aching or burning at rest or with elevation● Are relieved by dependency● Interfere with sleep

Also indicate the following:● Location (right or left leg or both)

— Forefoot— Toes

● Date of onset● Duration of symptoms● Frequency of occurrence

— Intermittent— Constant

Tissue loss To report a nonhealing wound, indicate the following:● Location● Onset/duration

ute Limb Ischemia

Characteristics Indicate if there is sudden onset of

● Pain● Paresthesia

Location Indicate the specific location of pain.

Symptom onset Indicate the onset and duration of symptoms.

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tient Assessment: Physical Evaluation

Pulses Indicate the characteristics of pulses in the following locations:● Femoral● Popliteal● Dorsalis pedis● Posterior tibial

Indicate if pulses are:● 0: Absent● 1: Diminished● 2: Normal● 3: Bounding

Bruits Indicate the presence or absence of bruits on auscultation in the following:● Carotid● Abdominal● Femoral● Subclavian

Elevation pallor Indicate the presence of pallor of the forefoot after elevating the leg 60° for 1 min.

Reperfusion delay Reperfusion delay (�40 s)

Dependent rubor Indicate if rubor of the foot is present when held in dependence after an elevation pallor maneuver.

Acute limb ischemia Acute limb ischemia is characterized by● Pallor● Pulselessness● Poikilothermia● Paralysis

— One of the following categories should be assigned:Œ I: Viable—Limb is not immediately threatened; no sensory loss; no muscle weakness; audible arterial and

venous DopplerŒ II: Threatened—Mild to moderate sensory or motor loss; inaudible arterial Doppler; audible venous DopplerŒ III: Irreversible—Major tissue loss or permanent nerve damage inevitable; profound sensory loss, anesthetic;

profound muscle weakness or paralysis (rigor); inaudible arterial and venous Doppler

Tissue loss (ischemic wound organgrene): characteristics

Tissue loss is characterized by● Dryness● Necrosis● Granulation

Tissue loss (ischemic wound organgrene): affected limb

Indicate the affected extremity/extremities. Choose 1 of the following:● Left● Right● Bilateral

Tissue loss (ischemic wound organgrene): location

Specify the location of tissue loss. Choose all that apply:● Distal aspect of leg or foot● Over bony prominence● Toe● Others

Tissue loss (ischemic wound organgrene): wound area

Indicate the measured area of the wound in centimeters.

Tissue loss (ischemic wound organgrene): infection

Indicate the presence or absence of infection. Choose 1 of the following:● Yes● No

Tissue loss (ischemic wound organgrene): type

Indicate the type of tissue loss. Choose 1 of the following:● Minor: nonhealing ulcer, focal gangrene with diffuse pedal ischemia● Major: extending above transmetatarsal level; functional foot no longer salvageable

Tissue loss (ischemic wound organgrene): depth/Wagner grade

Indicate the Wagner grade of the wound/gangrene. Choose 1 of the following:● Grade 0: Pre- or postulcerative lesion● Grade 1: Partial/full thickness ulcer● Grade 2: Probing to tendon or capsule● Grade 3: Deep with osteitis● Grade 4: Partial foot gangrene● Grade 5: Whole foot gangrene

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agnostic Testing:ninvasive Procedures

Ankle Brachial Index/Toe Brachial Index

Date of procedure Indicate the date the procedure was performed (mo/d/y).

Ankle systolic pressure Indicate the ankle systolic pressure of the right and left legs and whether it is recorded from the posterior tibial ordorsalis pedis arteries.

ABI value Indicate the ABI value for each leg. Choose 1 of the following:● Normal (ABI 1.00–1.40)● Abnormal (ABI �0.90)● Borderline (ABI 0.91–0.99)● Noncompressible arteries (ABI �1.40)

Great toe systolic pressure Indicate the right and left great toe systolic pressures.

TBI value Indicate the TBI value for each leg. A TBI value of �0.7 is abnormal.

Exercise Testing: Treadmill Exercise

Date of procedure Indicate the date exercise testing was performed (mo/d/y).

Protocol Specify the symptom-limited exercise protocol used (constant load/graded).

Postexercise ankle pressureand/or ABI

Indicate if immediate postexercise ankle pressure and/or ABI measurement were performed. Choose 1 of thefollowing:● Yes. If so, indicate value.● No

Walking time Indicate the following walking time in minutes:● Claudication onset time● Peak walking time

Distance Indicate the walking distance in meters or feet:● Claudication-onset walking distance● Peak walking distance

METS 1 MET is defined as 3.5 mL O2 · kg�1 · min�1. Indicate METS at peak exercise.

Alternative method A 6-min walk is the distance walked in 6 min on flat surface using standardized measurement procedures.It is reported in meters or feet.

Segmental Pressure Examination

Date of examination Indicate the date the segmental pressure examination was performed (mo/d/y).

Segmental pressure measurements ● Right and left brachial pressures● Right and left thigh pressures● Right and left low thigh pressures● Right and left thigh calf pressures● Right and left dorsalis pedis pressures● Right and left posterior tibial pressures

Indicate if there is a �20 mm Hg drop between the contiguous segments of the same leg, which can suggest thelocation of stenosis.

Pulse Volume Recording

Date of recording Indicate the date PVR was taken (mo/d/y).

Amplitude reduction Indicate the leg and location of PVR:● Right/left high thigh● Right/left low thigh● Right/left calf● Right/left ankle● Right/left metatarsal

Choose 1 of the following to describe pulse wave amplitude:● Normal● Abnormal● Mildly reduced● Moderately reduced● Severely reduced

Transcutaneous Oxygen Pressure

Date of measurement Indicate the date of measurement (mo/d/y).

TcPo2 measured Measurement of the pressure of oxygen on the surface of the skin. Indicate the following:● Right foot● Left foot

Value of TcPo2 Indicate the TcPo2 value in the right foot and left foot.

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Duplex Ultrasound


Artery imaged Indicate the artery imaged. Choose all that apply:● Aorta● Right/left CIA● Right/left EIA● Right/left common femoral artery● Right/left proximal profunda femoris artery● Right/left superficial femoral artery● Right/left popliteal artery● Right/left tibioperoneal trunk● Right/left anterior tibial artery● Right/left posterior tibial artery● Right/left peroneal artery

Peak systolic velocity Specify for

● Aorta● Right/left CIA● Right/left EIA● Right/left common femoral artery● Right/left proximal profunda femoris artery● Right/left superficial femoral artery● Right/left popliteal artery● Right/left tibioperoneal trunk● Right/left anterior tibial artery● Right/left posterior tibial artery● Right/left peroneal artery

Category of stenosis Specify for

● Aorta● Right/left CIA● Right/left EIA● Right/left common femoral artery● Right/left proximal profunda femoris artery● Right/left superficial femoral artery● Right/left popliteal artery● Right/left tibioperoneal trunk● Right/left anterior tibial artery● Right/left posterior tibial artery● Right/left peroneal artery

Indicate the category of stenosis (30):● Normal● 1%–49%● 50%–99%● Occlusion

Bypass graft Indicate location of proximal and distal anastomosis and type (e.g., in situ saphenous vein, reverse saphenous vein, PTFE).

Peak systolic velocity ofbypass graft

Indicate peak systolic velocity at proximal anastomosis, along conduit, and at distal anastomosis.

Ratios of peak systolic velocitiesalong bypass graft

Indicate ratio of peak systolic velocity of 2 contiguous segments at proximal anastomosis, along conduit, and atdistal anastomosis.

Category of bypass graft stenosis Bypass graft stenosis percentage. Indicate location and choose 1 of the following:● 0%–49%● 50%–99%● Occluded

Magnetic Resonance Angiography


Contrast use Indicate if gadolinium was used. Choose 1 of the following:● Yes● No

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Artery imaged Indicate the artery imaged. Choose all that apply:● Abdominal aorta● Right/left iliac (common, internal, external) artery● Right/left femoral (common, superficial, deep) artery● Right/left popliteal (above knee, below knee, both) artery● Right/left tibial/peroneal (anterior tibial, posterior tibial, peroneal) arteries

Lesion location Specify the location of the lesion.

Artery stenosis Indicate the severity of stenosis by quantitative analysis using the formula

100�(1�minimum lumen diameter)/maximum diameter of reference segment

Reconstitution Indicate if reconstitution was seen. Choose 1 of the following:● Yes● No

CT Angiography


Contrast used Indicate the type of contrast used. Choose 1 of the following:● Ionic contrast● Nonionic contrast; specify:

— Monomer— Dimer

Contrast volume Indicate the volume of contrast used in milliliters.

Slice thickness Indicate the slice thickness in millimeters.

Format: raw images Indicate if raw images were reviewed. Choose 1 of the following:● Yes● No

Format: reconstructed images Indicate if reconstructed images were reviewed. Choose 1 of the following:● Yes. If yes, specify

— Shaded surface images— Maximum intensity projection

● No

Artery imaged Indicate the artery imaged. Choose all that apply:● Abdominal aorta● Right/left iliac (common, internal, external) artery● Right/left femoral (common, superficial, deep) artery● Right/left popliteal (above knee, below knee, both) artery● Right/left tibial/peroneal (anterior tibial, posterior tibial peroneal) arteries

Lesion location Specify the location of the lesion.

Calcification Indicate if calcification is present. If present, specify the location. Choose 1 of the following:● None● Mild● Moderate● Severe



Reconstitution Indicate if reconstitution was seen. Choose 1 of the following:● Yes● No

agnostic Testing: Invasive Procedures

Catheter Angiography


Operator name Last name, first, middle

Anesthesia Indicate the type of anesthesia used. Choose 1 of the following:● General● Local

— Indicate if sedation was used. Choose 1 of the following:Œ YesŒ No

● Regional— With sedation— Without sedation

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Vascular access site Specify the vascular access site.

Contrast agent Indicate the contrast agent used:● Iodinated

— Ionic— Nonionic

Œ MonomerŒ Dimer

● Noniodinated (CO2)

Contrast volume Specify the contrast volume given.

Field size Indicate the field size in centimeters or inches.

Frame rate Indicate the FPS.

Image type Indicate the image type. Choose 1 of the following:● Cine● Digital images

Digital subtraction Indicate if digital subtraction was done. Choose 1 of the following:● Yes● No

Fluoroscopy time Indicate total fluoroscopy time recorded to the nearest 0.10 min. The time recorded should include the total timefor the procedure.

Artery imaged Indicate the artery imaged. Choose all that apply:● Abdominal aorta● Right/left iliac (common, internal, external) artery● Right/left femoral (common, deep, superficial) artery● Right/left popliteal (above knee, below knee, or both) artery● Right/left tibial/peroneal (anterior tibial, posterior tibial, peroneal) arteries

Lesion location Specify the location of the lesion (ostial, proximal third, middle third, and distal third).

Calcification Indicate if calcification is present. If present, specify the location.

Choose 1 of the following:● None● Mild● Moderate● Severe



Reconstitution Indicate if the artery is reconstituted by collaterals. Choose 1 of the following:● Yes

— If yes, indicate level.● No

Translesional pressure gradient Indicate the pressure measured proximal to the stenosis minus the pressure measured distal to the stenosis.

Also indicate the following:● Baseline pressure gradient

— Systolic— Mean— Diastolic

● Enhanced (hyperemic, postvasodilator) pressure gradient— Systolic— Mean— Diastolic

● Measurement timing— Simultaneous— Pullback

Complications Indicate any technical complications encountered during the diagnostic procedure: Choose all that apply:● Pseudoaneurysm● Atrioventricular fistula● Hematoma● Dissection● Vessel thrombosis● Vessel perforation● Atheromatous embolization

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● Contrast nephropathy● Contrast hypersensitivity● Requirement of intervention to prevent permanent impairment/damage

armacological Therapy formptoms of Claudication

Cilostazol Indicate if cilostazol has been prescribed for the patient. Choose 1 of the following:● Yes

— If yes, indicate the following:Œ DoseŒ Duration of treatment

● No

Pentoxifylline Indicate if pentoxifylline has been prescribed for the patient. Choose 1 of the following:● Yes

— If yes, indicate the following:Œ DoseŒ Duration of treatment

● No

ercise Rehabilitation fortermittent Claudication

Exercise Program Assessment

Functional status/quality of life Document functional ability at initiation and completion of the exercise program based on the following:● Claudication onset walking distance● Peak walking distance● METS achieved at peak exercise● 6-min walking test● Questionnaires

Total exercise time Document the total exercise time during the exercise session at initiation and completion of the exercise program.

Total rest time Document the total rest time spent during the exercise session at initiation and completion of the exercise program.

Walking time Document the duration of walking time at initiation and completion of the exercise program.

Exercise Prescription

Place Indicate the place where exercise is done. Choose 1 of the following:● Supervised facility● Home based

Mode of exercise Indicate the mode of exercise prescribed. Choose 1 of the following:● Treadmill

— Indicate initial speed and grade— Indicate final speed and grade

● Track walking— Indicate initial speed— Indicate final speed

● Cycling— Indicate initial speed and watts— Indicate final speed and watts

Progression Indicate the recommendation for progression of exercise.

Intensity level Indicate the recommended claudication pain intensity level before resting.

RPE Indicate the recommended range of RPE.

Duration of session Indicate the duration of the exercise session in minutes.

Frequency of session Indicate the number of days of exercise session per week

Duration of prescription Indicate how long the exercise prescription should be performed in number of sessions or number of weeks

erapeutic Procedures: Endovasculard Open Surgical Revascularization

Endovascular

Date Indicate the date the procedure was performed (mo/d/y).


Limb revascularized Indicate which limb was revascularized. Choose 1 of the following:● Right● Left● Both

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Procedure Indicate the procedure performed. Choose 1 or more of the following:● Balloon angioplasty● Cutting balloon● Stent

— Indicate if stent is drug eluting. Choose 1 of the followingŒ Yes

– If so, specify the type of drug-eluting stent.Œ No

● Stent graft● Atherectomy● Laser● Cryoplasty

Vessel Indicate the target vessel for revascularization. Choose all that apply:● Aorta● CIA● EIA● IIA● Common femoral artery● Superficial femoral artery● Deep femoral artery● Popliteal (above the knee)● Popliteal (below the knee)● Anterior tibial artery● Posterior tibial artery● Peroneal artery● Pedal arteries

Manufacturer Indicate the manufacturer of the device.

Model Indicate the model number of the device.

Diameter Indicate the maximum diameter of the device in millimeters.

Length Indicate the maximum length of the device in millimeters.

Time arrived in catheterization lab Indicate the time of patient arrival in the catheterization lab in hours:minutes.

Last catheter removed Indicate the date (mo/d/y) and time (h:min) the last catheter was removed.

Thrombolytic agent Indicate the thrombolytic agent used. Specify the following:● Specific thrombolytic agent used● Route of delivery● Dosage● Duration of infusion

Antithrombotic agent Indicate the antithrombotic agent used. Specify the following:● Specific antithrombotic agent used. Choose 1 of the following:

— Unfractionated heparin— Low–molecular-weight heparin— Fondaparinux— Direct thrombin inhibitor

● Route of delivery● Dosage● Duration of infusion

Antiplatelet agent Indicate the antiplatelet agent used. Specify the following:● Dosage

Closure device Indicate if a closure device was used. Choose 1 of the following:● Yes. Specify the following:

— Manufacturer— Model

● No

Contrast Indicate type of contrast used. Choose 1 of the following:● Iodinated

— Ionic— Nonionic— Monomer

Œ Dimer● Noniodinated (CO2)

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Device utilization Indicate the devices used for the procedure. Choose all that apply:● Guidewires● Guiding catheters● Intravascular ultrasound● Angioplasty balloons● Cutting balloon● Infusion catheter● Laser catheter● Thrombectomy device● Atherectomy device● Reentry device● Thermal balloon● EPD● Stent● Drug-eluting stent● Stent graft

Technical outcome Indicate the technical outcome of the procedure. Specify the following:● Postprocedure translesional gradient● Residual percent stenosis

Technical complication Indicate any technical complications encountered during the procedure: Choose all that apply:● Vessel perforation● Embolization (loss of runoff vessel)● Dissection● Vasospasm● Access site bleeding

Open Surgery



Location Indicate which limb the procedure was done. Choose 1 of the following:● Right● Left● Both

Procedure type Indicate the type of procedure performed. Choose 1 of the following:● Primary/secondary● Bypass

— Inflow/outflow— Anatomic/extra-anatomic

● Endarterectomy● Thrombectomy● Graft revision

Proximal anastomotic site Indicate the proximal anastomotic site and side. Choose 1 of the following:● Thoracic aorta● Abdominal aorta● CIA● EIA● Common femoral artery● Proximal superficial femoral artery● Distal superficial femoral artery● Profunda femoral artery● Proximal popliteal artery● Distal popliteal artery● Tibioperoneal artery● Proximal anterior tibial artery● Distal anterior tibial artery● Proximal posterior tibial artery● Distal posterior tibial artery● Proximal peroneal artery● Distal peroneal artery● Dorsalis pedis/tarsal artery

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Distal anastomotic site Indicate the distal anastomotic site. Choose 1 of the following:● CIA● EIA● Common femoral artery● Proximal superficial femoral artery● Distal superficial femoral artery● Profunda femoral artery● Proximal popliteal artery● Distal popliteal artery● Tibioperoneal artery● Proximal anterior tibial artery● Distal anterior tibial artery● Proximal posterior tibial artery● Distal posterior tibial artery● Proximal peroneal artery● Distal peroneal artery● Dorsalis pedis/tarsal artery

Graft material Indicate the type of graft material used for the procedure. Choose 1 of the following:● Autogenous

— Specify the harvest site. Choose 1 of the following:Œ LeftŒ Right

— Specify the vein used. Choose 1 of the following:Œ Great saphenous vein, in situŒ Great saphenous vein, nonreversedŒ Great saphenous vein, reversedŒ Arm veinŒ Small saphenous veinŒ Composite veinŒ Vein patch

● Autogenous-prosthetic composite● Prosthetic

— Specify the type. Choose 1 of the following:Œ PTFEŒ Heparin-coated PTFEŒ DacronŒ Other (specify)

Graft diameter Specify graft diameter:● Prosthetic● Vein

Anesthesia Indicate type of anesthesia used. Choose 1 of the following:● General● Local

— Indicate if sedation was used. Choose 1 of the following:Œ YesŒ No

● Regional— Epidural— Spinal— Indicate if sedation was used. Choose 1 of the following:

Œ YesŒ No

Technical outcome Indicate the technical outcome of the procedure. Specify the following:● Postprocedure translesional gradient● Residual percent stenosis

Completion study Indicate the type of study performed after the procedure. Choose 1 of the following:● Angiogram● Duplex ultrasound

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Estimated blood loss Indicate the estimated amount of blood loss in milliliters.

Transfused blood products Indicate the blood products transfused to the patient. Choose all that apply:● Auto transfused blood (specify volume used)● Packed RBCs● Fresh frozen plasma● Platelets● Other (specify)

Operative time Indicate the total time of the procedure in hours:minutes.

tcomes of Endovascular/en Surgery Procedures

Time point Indicate the period at which outcome measures are assessed. Choose all that apply:● Periprocedure (24 h)● Procedure related (30 d)● 3 mo● 6 mo● 1 y

Serious adverse event Indicate major clinical complications arising from the management or treatment of the disease.Choose 1 of the following:● Yes

— Specify the serious adverse event. Choose all that apply:Œ Hospitalization/prolonged hospitalizationŒ Loss of limb or function of organ systemŒ Persistent or significant disability or incapacityŒ Death

● No

Complications ofendovascular procedure

Indicate postoperative clinical events or conditions associated with the endovascular procedure.Choose all that apply:● Pseudoaneurysm● AV fistula● Hematoma● Dissection● Vessel thrombosis● Vessel perforation● Atheromatous embolization● Contrast nephropathy● Contrast hypersensitivity● Infection● Requirement of intervention to prevent permanent impairment/damage

Complications of open surgery Indicate complications of open surgery. Choose all that apply:● Major complication

— Death— Shock (cardiogenic or septic)— MI— Stroke (ischemic, hemorrhagic, unknown type)— Renal failure— Prolonged hospitalization— Infection— Coagulopathy— Thrombosis— Compartment syndrome— Acute graft failure

● Minor complication (specify)

inical Outcomes

Limb-Related Outcomes

Time point Indicate the period at which outcome measures are assessed. Choose all that apply:● 1 mo● 3 mo● 6 mo● 1 y

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nal/mesenteric artery disease, AAAs, and cerebrovascularsease; and comorbid conditions, such as congestive heartilure, pulmonary insufficiency, and chronic kidney disease.ore detailed data elements for each PAVD are provided ine subsequent tables. The general elements table also listsmponents of the physical examination, such as height, weight,dy mass index, vital signs, and aspects of the cardiac andscular examination. Detailed elements of the examination areovided in subsequent tables as applicable to each PAVD.ommon laboratory values are also included, such as themplete blood count, renal and hepatic function tests, lipidvels, cardiac enzymes, markers of inflammation, and tests for

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Limb-related outcomes: symptoms ● Claudication— None— Unchanged— Improved— Worsened

● Ischemic rest pain● Ischemic tissue loss● Amputation

Limb-related outcomes:functional capacity

Walking ability

● Pain-free walking distance (in m● Maximum walking distance (in

Functional status/quality of life● Questionnaire assessment

— Community-based walking (P— Generic health status: SF-36— PAD-specific quality of life: V

● Patient anecdote

Noninvasive assessment of outcome ● Limb perfusion pressure and/or● Graft scan● Other imaging (CTA or MRA)

Procedure-related outcomes Patency

● Primary● Assisted● Secondary

Limb-related outcomes:wound healing

Wound healing characteristics. Co● Description of dressing● 1-wk change in area● 4-wk change in area● Presence and amount of granu● Presence of reepithelialization● Presence of fibrin slough

Cardiovascular Outcomes

Cardiovascular outcomes New cardiovascular ischemic even● Angina● MI● Coronary artery revascularizatio● CHF● TIA● Stroke (ischemic, hemorrhagic,● Carotid artery revascularization● Death

ABI indicates ankle brachial index; CHF, congestive heart failure; CIA, commoA, external iliac artery; EPD, embolic protection device; FPS, frame rate per secofarction; MRA, magnetic resonance angiography; PAD, peripheral artery diseae; RBC, red blood cell; RPE, rating of perceived exertion; SF-36, Short Form 3ygen; and TIA, transient ischemic attack.

herited and acquired thrombophilia. Additional general ele- ti

ents include current pharmacotherapy, such as antiplatelet/ticoagulant drugs, medications to treat atherosclerotic riskctors, and drugs for comorbid cardiovascular conditions.

.2. Lower Extremity PAD Tablef Data Elementsower extremity PAD is defined as atherosclerotic diseaseat affects the arteries supplying the legs (2). Affected bloodssels may include the aorta and the iliac, femoral, popliteal,

bial, and peroneal arteries and their major branches. Theta elements defined in Table 2 enable detailed documenta-

or time (in minutes)or time (in minutes)

ific): Walking Impairment Questionnaire, othersham Health Profile, EuroQol, Sickness Impact Profile, and othersL Questionnaire, PADQOL, and others

ll that apply:

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rtery; CT, computed tomography; CTA, computed tomographic angiography;internal iliac artery; METS, metabolic equivalent of task score; MI, myocardial, polytetrafluoroethylene; PVR, pulse volume recording; QoL/QOL, quality of

h Survey; TBI, toe-brachial index; TcPo2, transcutaneous partial pressure of

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story

History of present illness Indicate if the patient has been having any of the following symptoms and specify duration. Choose all that apply:● No symptoms● Abdominal pain● Back pain● Groin pain● Leg pain

Past medical history Indicate if the patient has any of the following past medical history. Choose all that apply:● Aneurysms or dissection

— Indicate location(s) and extent● Prior aneurysm surgery● Marfan syndrome● Ehlers-Danlos syndrome● Aortic surgery or endovascular repair

— Indicate location(s), type, and extent of repair● Aortitis● Other inflammatory or infectious disorders:

— Giant cell arteritis— Takayasu’s arteritis— Behçet’s syndrome— Infection

Family history Indicate if the patient has any of the following family history. Choose all that apply:● Aneurysms or dissections

— Indicate location(s)● Marfan syndrome● Ehlers-Danlos syndrome● Loeys-Dietz syndrome● Other

ysical Assessment

Abdominal Aorta

Body habitus Indicate the patient’s body habitus. Choose 1 of the following:● Thin● Normal● Obese

Aortic pulsations Indicate the presence or absence of palpable abdominal aortic pulsations. Choose 1 of the following:● Absent● Present

Aortic pulsation characteristics Indicate the characteristics of aortic pulsation. Choose 1 of the following:● Normal● Expansile

Aortic diameter Estimate the diameter of AAA by palpation in inches or centimeters.

Abdominal bruit Indicate the absence or presence of abdominal bruit. Choose 1 of the following:● Absent● Present

Abdominal aortic area tenderness Indicate the absence or presence of tenderness in the abdominal aortic area. Choose 1 of the following:● Absent● Present

Abdominal tenderness Indicate the absence or presence of abdominal tenderness in areas other than the abdominal aortic area.Choose 1 of the following:● Absent● Present

Abdominal tenderness location Indicate location of abdominal tenderness.

Lumbar spinal tenderness Indicate the absence or presence of lumbar spinal tenderness. Choose 1 of the following:● Absent● Present

Pulses Indicate the characteristics of pulses in the following locations:● Femoral● Popliteal● Dorsalis pedis● Posterior tibial

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Indicate if pulses are:● 0: Absent● 1: Diminished● 2: Normal● 3: Bounding or expansile

agnostic Procedures: Noninvasive

Ultrasonography


Aneurysm: type Indicate the type of aneurysm. Choose 1 of the following:● Fusiform● Saccular● Pseudoaneurysm

Aneurysm: size Indicate the size of the aneurysm in millimeters in anteroposterior, transverse, andlongitudinal dimensions.

Aneurysm: distance Indicate the distance from the most proximal portion of the aneurysm to its most distalportion in millimeters.

Thrombus Indicate if thrombus is present. Choose 1 of the following:● Yes● No

Dissection Indicate if dissection is present. Choose 1 of the following:● Yes● No

Leak Indicate if leak is present. Choose 1 of the following:● Yes● No

Magnetic Resonance Imaging


Method of MRA Indicate the method of MRA used. Choose 1 of the following:● Contrast-enhanced MRA: White blood angiogram obtained by lowering the T1 relaxation

time of blood below the surrounding tissue● Time-of-flight MRA: White blood angiogram generated by using the in-flow effect

Contrast used Indicate if gadolinium was used. Choose 1 of the following:● Yes● No

Aneurysm: location Indicate location of the aneurysm. Choose any of the following:● Thoracoabdominal:

— Type 1— Type 2— Type 3— Type 4

● Abdominal— Indicate the proximal extent of the aneurysm:

Œ SuprarenalŒ JuxtarenalŒ Infrarenal

— Indicate whether the distal extent of the aneurysm is the aorta or whether it involvesthe iliac arteries.Œ AortaŒ Aortoiliac

– Bi-iliac– Left iliac– Right iliac


Aneurysm: size Indicate the size of the aneurysm in millimeters by recording the maximum axial dimensionmeasured from outer margin to outer margin. The axial dimension should be perpendicularto blood flow.

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Aneurysm: distance Indicate the distance from the most proximal portion of the aneurysm to the most distalportion in millimeters.




Characteristics of other arteries Indicate other arteries imaged and indicate the patency or severity of stenosis.Choose all that apply:● Celiac artery● Superior mesenteric artery● Inferior mesenteric femoral artery● Right renal artery● Left renal artery● Right/left CIA● Right/left external iliac artery● Right/left common femoral artery

Computed Tomography

CT method Indicate method of CT. Choose 1 of the following:● Standard● Spiral (helical)● Electron beam


Contrast used Indicate the type of contrast used. Choose 1 of the following:● Ionic● Nonionic; specify:



Slice thickness Indicate the slice thickness in millimeters.

Format: raw images Indicate if raw images were reviewed. Choose 1 of the following:— Yes— No

Format: reconstructed images Indicate if reconstructed images were reviewed. Choose 1 of the following:● Yes. If yes, specify:— Shaded surface images— Maximum intensity projection● No

Aneurysm: location Indicate location of the aneurysm. Choose any of the following:● Thoracoabdominal:




— Indicate whether the distal extent of the aneurysm is the aorta or whether it involvesthe iliac arteries:Œ AortaŒ Aortoiliac


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Aneurysm: size Indicate the size of the aneurysm in millimeters by recording the maximum axial dimensionfrom outer margin to outer margin. The axial dimension should be perpendicular to blood flow.


Aortic neck morphology Indicate each of the following:● Presence or absence of calcification● Presence or absence of thrombus within the neck● Degree of angulation in the neck● Diameter of the neck● Length of the neck from the lowest renal artery to the origin of the aneurysm




Characteristics of other arteries Indicate other arteries imaged and the patency or severity of stenosis. Choose all that apply:● Celiac artery● Superior mesenteric artery● Inferior mesenteric femoral artery● Right renal artery● Left renal artery● Right/left CIA● Right/left external iliac artery● Right/left common femoral artery

agnostic Procedures: Invasive

Catheter Angiography


Contrast Indicate the contrast used. Specify the following:● Type● Amount in milliliters

Fluoroscopy time Indicate the total fluoroscopy time recorded to the nearest 0.10 min. Time recorded shouldinclude the total time for the procedure.

Aneurysm: location Indicate the location of the aneurysm. Choose any of the following:● Thoracoabdominal:




— Indicate whether distal extent of aneurysm is the aorta or whether it involves theiliac arteries:Œ AortaŒ Aorto-iliac


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Aneurysm: type Indicate type of aneurysm. Choose 1 of the following:● Fusiform● Saccular● Pseudoaneurysm

Aneurysm: size Indicate the size of aneurysm in millimeters by recording the maximum axial dimensionmeasured from outer margin to outer margin. The axial dimension should be perpendicularto blood flow.





Characteristics of other arteries Indicate other arteries imaged and the patency or severity of stenosis. Choose all that apply:● Celiac artery● Superior mesenteric artery● Inferior mesenteric femoral artery● Right renal artery● Left renal artery● Right/left CIA● Right/left external iliac artery● Right/left internal iliac artery● Right/left common femoral artery

eatment:vasive Therapeutic Procedures

Open AAA Repair



Extent of aneurysm Indicate the extent of aneurysm in the following areas:● Thoracoabdominal:


● Associated dissection— Yes— No

Infrarenal:● Aorta● Aortoiliac

— Bi-iliac— Left iliac— Right iliac

Clamping site: proximal Specify the proximal clamping site (or proximal control). This may include the following:

Thoracoabdominal:● Above the mesenteric arteries● Descending thoracic aorta● Hypothermic circulatory arrest (no clamp)● Distal to left subclavian artery● Proximal to left subclavian artery

Infrarenal:● Infrarenal● Supraceliac● Suprarenal

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Clamp time Indicate the following:● Proximal time● Time to restoration of visceral flow● Total clamp time

Clamping site: distal Specify the distal clamping site. This may include the following:

Thoracic:● Clamp site● Segmental clamping

— Yes— No

Infrarenal:● Aorta● CIA● EIA and IIA

Neuroprotection technique(thoracoabdominal)

Indicate neuroprotection techniques used. Choose all that apply:● Clamp and sew (no protection)● Preoperative imaging of spinal perfusion● Retrograde perfusion

— Atrial-femoral bypass— Axillo-femoral bypass— Femoro-femoral bypass— Shunt— Others: specify

● Neurologic monitoring● CSF drainage● Systemic cooling● Epidural cooling● Reimplantation of intercostal arteries

— Specify how many

Graft Indicate type of graft used for procedure. Choose 1 of the following:● Polyester woven● Polyester knitted● PTFE

Infrarenal:● Tube graft● Bifurcated graft● Site of distal anastomoses (iliac or femoral arteries)

Management of visceral segment forthoracoabdominal

Indicate how visceral segment was managed. Choose 1 of the following:● Visceral patch, including celiac artery, SMA, right renal artery, and left renal artery.● Visceral patch, including celiac artery, SMA, and right renal artery with left renal artery

either bypassed or implanted into aortic graft separately● Individual bypasses to visceral and renal arteries.● Indicate if visceral organ protection was used

— If so, specify type (perfusion, cold infusion)

Management of inferior mesentericartery

Indicate how inferior mesenteric artery was managed. Choose 1 of the following:● Chronically occluded● Oversewn● Reimplanted

Intraoperative Details forOpen AAA Repair

Additional procedures Indicate other procedures performed. Choose all that apply:● Renal artery bypass/endarterectomy● Visceral artery procedure (specify)● Other (specify)

Intraoperative complications Indicate if there were any intraoperative complications. Choose 1 of the following:● Yes (specify)● No

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Endovascular AAA Repair



Aortic and iliac diameters and lengths Indicate aortic and iliac diameters and lengths● Aortic diameter at lowest renal artery● Aortic diameter 1.5 cm below lowest renal artery● Aortic diameter at terminal aorta● Maximum diameter of right CIA● Maximum diameter of left CIA● Minimum diameter of right EIA● Minimum diameter of left EIA● Length of aorta from lowest renal artery to aortic bifurcation● Length from aortic bifurcation to right IIA● Length from aortic bifurcation to left IIA

Graft Indicate type of graft used. Choose 1 of the following:● Fixation

— Infrarenal— Suprarenal

● Unibody● Bifurcated

— 1 docking limb— 2 docking limbs

Hypogastric arteries excluded Indicate number of hypogastric arteries excluded. Choose 1 of the following:● 0● 1● 2

Management of inferior mesentericartery

Indicate how inferior mesenteric artery was managed. Choose 1 of the following:● Chronically occluded/covered● Coil occluded

Extension used Indicate extension used. Choose 1 of the following:● Distal

— Number and size placed— Landing zone

Œ CIAŒ EIA

● Proximal— Number and size placed

Adjunctive procedures Indicate the adjunctive procedures used. Choose 1 of the following:● Adjunctive angioplasty or stent required. Specify the following:

— Side: indicate left or right— Location: CIA, IIA, EIA— Indication

● Conduit used for insertion of endograft. Specify the following:— Side: indicate left or right— Size and type of graft material of conduit— Indication

● Accessory renal artery management. Specify the following:— Side: indicate left or right— Site of artery— Size of artery— Treatment:

Œ EmbolizationŒ Coverage

● Iliac embolization. Specify the following:— Side: indicate left or right— Size: balloon or stent— Indication

Endograft configuration Indicate the configuration of the endograft:● Aorto–bi-iliac● Aorto–uni-iliac graft with femoral artery to femoral artery bypass and

iliac artery occlusion

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Aortic neck morphology Indicate each of the following:● Presence or absence of calcification● Presence or absence of thrombus within neck● Degree of angulation in the neck. Specify C-arm correction angle in degrees.● Diameter of the neck● Length of the neck from the lowest renal artery to the origin of the aneurysm

Intraoperative Details for EndovascularAAA Repair

Endoleak present Indicate the type of endoleak present at the end of the case. Choose 1 of the following:● Type I● Type II● Type III● Type IV● Undetermined

Limb kinking If present, specify the following:● Site● Size● How it was resolved

Patency of arteries Indicate the patency of the arteries. Specify the following:● Right/left renal arteries:

— Number● Right/left accessory renal arteries

— Number● Right/left common/external iliac arteries

Intraoperative complications Indicate if there were any intraoperative complications. Choose 1 of the following:● Yes. If yes, choose all that apply:

— Arterial injuryŒ Indicate right or left sideŒ Indicate artery injured

— EmbolizationŒ Indicate site

— Inadvertent covering of arteryŒ Indicate site

● No

Invasive Therapeutic Procedures: OtherOperative Details

Estimated blood loss Indicate the total amount of blood loss in milliliters.

Transfused blood products Indicate the blood products transfused to the patient. Choose all that apply:● Auto transfused blood (specify volume)● Packed RBCs● Fresh frozen plasma● Platelets● Other (specify)

Operative time Indicate the total time of procedure in hours:minutes.

Invasive Therapeutic Procedures:Postprocedure Details

Time to extubation Indicate when the patient was extubated post procedure. Choose 1 of the following:● Immediate● Postoperative day (specify day number)

Oral intake Indicate the day of oral intake.

Length of stay in ICU Indicate the length of stay in the ICU. Specify the number of days or indicate notapplicable.

Length of stay in step-down unit Indicate the length of stay in a step-down unit. Specify the number of days or indicate notapplicable.

Postoperative complications Indicate postoperative complications. Choose all that apply:● Bleeding● Cardiac● Infections● Pulmonary

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● Renal● Neurological● Reoperation● Other (specify)

Total length of stay Indicate total length of stay in the hospital in number of days.

Discharge status (21) Indicate the patient’s discharge status. Choose 1 of the following:● Discharged to home or self-care:

— This includes discharge to home; jail or law enforcement; home on oxygen if DMEonly; any other DME only; group home, foster care, and other residential carearrangements; outpatient programs such as partial hospitalization or outpatientchemical dependency programs; assisted living facilities that are not state designated.

● Discharged/transferred to short-term general hospital for inpatient care● Discharged/transferred to SNF with Medicare certification in anticipation of skilled care● Discharged/transferred to ICF● Discharged/transferred to standard rehabilitation facility● Discharged/transferred to ventilator rehabilitation facility● Discharged/transferred to another type of healthcare institution other than the above● Patient died

tient Education/Counseling

Medication instruction Verbal and written medication instructions provided to patient and/or family

Recognition of new orworsening symptoms

Verbal and written instructions provided to patient and/or family (by physician or nurse)about new or worsening symptoms and when to call the physician

Diet counseling Advice given or discussion held with patient and/or family about the importance of diet inrelation to lowering cardiovascular risk. May include● Sodium restriction● Fluid restriction● Referral to dietitian for weight management and/or advanced nutritional instruction● Other (specify)

Smoking cessation counseling Advice given or discussion held with patient (by physician, nurse, or other personnel) aboutthe importance of stopping smoking. May include● Counseling (may be basic or advanced)● Written materials● Referral to smoking cessation program● Drugs to help with smoking cessation

Activity counseling Advice given or discussion held with patient and/or family about activity level andrestrictions in activity and/or exercise recommendations

llow-Up

Open repair Documentation of follow-up evaluation of patient 2 to 4 wk after discharge should include● Physical examination● Duplex ultrasound to check integrity of repair

CT scan of chest, abdomen, and pelvis should be considered within 5 y to evaluate forsynchronous aneurysms.

Endovascular/hybrid approach Documentation of follow-up evaluation of patient 4 wk after discharge should include● Physical examination● CT scan of abdomen and pelvis● Plain film of abdomen to access stent integrity and migration

tcomes of Open AAA and Endovascularpair

Time point Indicate the period at which outcome measures are assessed. Choose all that apply:● Periprocedure (24 h)● Procedure related (30 d)● 3 mo● 6 mo● 1 y● Other

Serious adverse event Indicate major clinical complications arising from management or treatment of the disease.● Yes

— Specify serious adverse event from complication list below.● No

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Complications ofendovascular repair

Indicate postoperative clinical events or conditions associated with endovascular procedure.Choose all that apply:● Major complication

— Death— MI (also see cardiovascular complications below):

Œ Prolonged hospitalizationŒ Loss of limb or function of organ systemŒ Persistent or significant disability or incapacityŒ DissectionŒ PseudoaneurysmŒ Vessel thrombosisŒ Vessel rupture

— StrokeŒ CerebralŒ Spinal cord stroke

— Other life-threatening major complication (specify)Œ SeromaŒ HematomaŒ Mesenteric ischemiaŒ Renal failureŒ PneumoniaŒ Atheromatous embolizationŒ DVTŒ Contrast nephropathyŒ Contrast hypersensitivityŒ InfectionŒ Requirement for intervention to prevent permanent impairment/damageŒ Postimplant syndrome


Complications of open repair Indicate complications of open surgery. Choose all that apply:● Major complication


Œ Prolonged hospitalizationŒ Loss of limb or function of organ systemŒ Persistent or significant disability or incapacityŒ DissectionŒ PseudoaneurysmŒ Vessel thrombosisŒ Vessel rupture


— Other life-threatening major complication (specify)Œ SeromaŒ HematomaŒ Mesenteric ischemiaŒ Renal failureŒ PneumoniaŒ Atheromatous embolizationŒ DVTŒ Contrast nephropathyŒ Contrast hypersensitivityŒ InfectionŒ Requirement for intervention to prevent permanent impairment/damageŒ Postimplant syndrome


inical Outcomes

Time point Indicate period at which outcome measures are assessed. Choose all that apply:● 1 mo● 3 mo● 6 mo● 1 y

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y of limb ischemia. The table includes data elements used inysiologic diagnostic tests, such as the ankle brachial index,

eadmill exercise test, limb segmental pressure measurements,d pulse volume recordings. It also provides detailed elementsimaging tests, including duplex ultrasonography, magnetic

sonance angiography, computed tomographic angiography,d catheter-based radiocontrast angiography, such as the arteryaged and the location and severity of stenoses. Data elements

levant to treatment include pharmacotherapy and exercisehabilitation for claudication. Table 2 also includes detailedta elements for both endovascular and open surgical revascu-rization such as the target vessel, the specific procedure,tcomes, and complications.

.3. AAA Table of Data Elementsable 3 provides a list and definition of data elementslevant to AAAs. Atherosclerosis is associated with thegenerative changes found in the aortic wall of AAA,

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Graft or Endograft-Related Outcomes

Graft or endograft-related outcomes ● Patenc— Prim— Assi— Seco

● Ischem● Ischem● Amput

Cardiovascular Outcomes

Cardiovascular outcomes New card● Angina● MI● Corona● CHF● TIA● Ischem● Hemor● Stroke● Death

Outcomes Assessment

Noninvasive assessmentof outcome

● Pulse● ABI

Long-Term Outcomes of Open AAARepair and Endovascular AAA Repair

Open AAA repair: long-term outcomes ● Infectio● Aortoe● Second● Paragr● Need f

Endovascular AAA repair: long-termoutcomes

● Infectio● Aortoe● Second● Paragr● Endole● Need f

AAA indicates abdominal aortic aneurysm; ABI, ankle brachial index; CHF, congmography; DME, durable medical equipment; DVT, deep venous thrombosis;ternal iliac artery; MI, myocardial infarction; MRA, magnetic resonance angiogtery; SNF, skilled nursing facility; and TIA, transient ischemic attack.

ough it is not necessarily causal. For this reason, it is ar

cluded in this document as a PAVD, although there areher much less common causes of AAA, such as aortitis,fection, aortic dissection, and inherited disorders of con-ctive tissue. The data elements defined in Table 3 enablecumentation of symptoms, relevant medical history, ande physical assessment of AAA. The table comprises de-iled elements of diagnostic imaging tests, including ultra-nography, magnetic resonance imaging, and computedmography, such as aneurysm type, size, location, and otheraracteristics. Additional elements relate to endovasculard open surgical repair and include details of the procedures,tcomes, and complications.

.4. Renal and Mesenteric Artery Diseaseable of Data Elements

the context of this document, renal artery disease is definedatherosclerotic disease that causes stenosis or occlusion of

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dary procedure

eart failure; CIA, common iliac artery; CSF, cerebrospinal fluid; CT, computedrnal iliac artery; ICF, intermediate care facility; ICU, intensive care unit; IIA,TFE, polytetrafluoroethylene; RBC, red blood cell; SMA, superior mesenteric

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Hypertension suggestive of renal arterydisease

● New-onset hypertension in those �30 or �55 y of age● Accelerated hypertension● Refractory hypertension● Hypertension and concomitant atherosclerotic disease in other vascular territories● Hypertension urgency/emergency

History of acute renal insufficiency History of reduced renal function for �3 mo (see “chronic kidney disease” element). Year of occurrence ofand precipitant for acute renal insufficiency (e.g., following treatment with angiotensin-converting enzymeinhibitor or angiotensin receptor blocker) may be specified.

Chronic kidney disease Current or previous history of chronic kidney disease. Chronic kidney disease is defined as either kidneydamage or GFR � 60 mL/min/1.73 m2 for �3 mo. Kidney damage is defined as pathologic abnormalitiesor markers of damage, including abnormalities in blood or urine tests or imaging studies.

Indicate the patient’s stage of disease:● Stage 0: No known kidney disease● Stage 1: Kidney damage with normal or high GFR: �90 mL/min/1.73 m2

● Stage 2: Kidney damage with mildly decreased GFR: 60–89 mL/min/1.73 m2

● Stage 3: Moderately decreased GFR: 30–59 mL/min/1.73 m2

● Stage 4: Severely decreased GFR: 15–29 mL/min/1.73 m2

● Stage 5: Kidney failure: GFR �15 mL/min/1.73 m2 or on dialysis

Note: GFR may be estimated using the serum creatinine MDRD formula:

eGFR�186 (serum creatinine)�1.154 (age)�0.203 (0.742 [if female]) (1.210 [if black])


Cause of chronic kidney disease (if present) ● Glomerular disease● Tubular/interstitial disease● Obstructive uropathy● Polycystic kidney disease● Other (specify)● Unknown

Other kidney disorder ● Single kidney● Cancer● Nephrectomy● Past trauma● Other

Recurrent “flash” pulmonary edema withoutcoronary ischemia/left ventriculardysfunction

Episodes of heart failure or pulmonary edema in the absence of a clear-cut cardiac cause such as● Active coronary ischemia● Systolic dysfunction on echocardiography

Other cardiovascular disease related torenal artery disease

Coronary artery disease, PAD, carotid artery disease, AAA

ninvasive Diagnostic Procedures

Duplex Ultrasound

Date of procedure Indicate the date of the procedure (mo/d/y).

Artery imaged Indicate artery imaged:● Right renal artery● Left renal artery

Peak systolic velocity ● Aorta● Proximal, mid-, distal right renal artery● Proximal, mid-, distal left renal artery

Ratio of renal to aortic peak systolicvelocities

Record ratio for right and left renal arteries.

Specify for right and left renal arteries. Choose 1 of the following (31):● 0%–59%● 60%–99%● Occluded

Location of stenosis Indicate side (right or left) and location of stenosis. Choose all that apply:● Proximal● Mid● Distal

Kidney size Indicate maximum pole-to-pole renal length in centimeters.

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Resistive index (peak systolic velocity�end diastolic velocity)/peak systolic velocity● Specify for right and left kidney

Assessment of aorta Identify atherosclerosis, stenosis, occlusion, and/or aneurysm of the abdominal aorta.




Location of stenosis Indicate side (right or left) and location of stenosis. Choose all that apply:● Proximal● Mid● Distal

Location of stenosis: specific location inrenal artery

Indicate side (right or left) and location of stenosis. Choose all that apply:● Main renal artery ostium● Main renal artery postostium (�1 cm from ostium)● Segmental renal artery● Intrarenal renal artery



Aorta Identify atherosclerosis, stenosis, occlusion, and/or aneurysm of the abdominal aorta.

Kidney size Indicate the maximum pole-to-pole renal length in centimeters.

Symmetry of renal perfusion Consistency and equality of renal blood flow in both kidneys

Symmetry of renal excretion Symmetry of rate of excretion of contrast agent from kidney

Renal artery morphology ● FMD● Atherosclerosis

Computed Tomographic Angiography






Indicate the side (right or left) and location of stenosis. Choose all that apply:● Main renal artery ostium● Main renal artery postostium (�1 cm from ostium)● Segmental renal artery● Intrarenal renal artery




Kidney size Indicate the maximum longitudinal renal length in centimeters.

Symmetry of renal perfusion Consistency and equality of renal blood flow in both kidneys

Symmetry of renal excretion Symmetry of rate of excretion of contrast agent from kidney


Captopril Renography


Operator Last name, first, middle

Symmetry Indicate whether there is equal uptake and excretion of radiotracer within kidneys.

Renogram curve Absolute time-activity curves pre- and postcaptopril, including peak and time to half-activity after peak

The time activity curve consists of the● Vascular phase● Secretory or functional phase● Excretory phase

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vasive Diagnostic Procedure

Catheter-Based Angiography



Vascular access site Specify the vascular access site.

Contrast agent Indicate the contrast agent used:● Iodinated

— Ionic— Nonionic

Œ MonomerŒ Dimer

● Noniodinated (CO2)

Contrast volume Specify contrast volume given.

Fluoroscopy time Indicate the total fluoroscopy time recorded during the procedure to the nearest 0.10 min.

Catheter position ● Selective● Nonselective

Renal perfusion Were all renal arteries identified (i.e., are there unexplained perfusion defects in the nephrogram phase)?


Indicate the side (right or left) and location of stenosis. Choose all that apply:● Main renal artery ostium● Main renal artery postostium (�1 cm from ostium)● Segmental renal artery● Intrarenal renal artery




Kidney size Maximum longitudinal renal length in centimeters

Symmetry of renal perfusion Assess the consistency and equality of renal blood flow in both kidneys.


Complications Indicate complications related to the diagnostic procedure. If a concurrent endovascular procedure isperformed, report under endovascular complications. Choose all that apply:● Pseudoaneurysm● AV fistula● Hematoma● Dissection● Vessel thrombosis● Vessel perforation● Atheromatous embolization● Contrast nephropathy● Contrast hypersensitivity● Requirement of intervention to prevent permanent impairment/damage● None

edical Therapies

Antihypertensive therapy Indicate name, dose, frequency of specific antihypertensive agent(s) used; address the use ofangiotensin-converting enzyme inhibitors/angiotensin II receptor antagonists.

Antilipidemic therapy Indicate the name, dose, and frequency of specific lipid-lowering agent(s) used.

Antiplatelet therapy Indicate the name, dose, and frequency of specific antiplatelet agent(s) used.

vasive Therapeutic Procedures

Renal Artery Angioplasty/Stenting



Angioplasty/stenting Choose 1 of the following:● Balloon angioplasty alone● Stent

Balloon length Indicate the length of the balloon used in millimeters.

Nominal balloon diameter Indicate the diameter of the balloon at initial inflation and final inflation in millimeters.

Target renal artery Indicate whether the target vessel for the procedure is the right or left renal artery.

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Current procedure part of clinical trial Indicate whether the procedure is part of a clinical trial. Choose one:● Yes

If yes, indicate the trial type:— IDE— Postmarket approval— Other (specify)

● No

Anesthesia Indicate if the patient received general anesthesia, conscious sedation, local anesthesia, or no anesthesiaduring the current procedure.

Procedure Indications andAnatomic Variables

Clinical indications ● Hypertension● Renal insufficiency● CHF/pulmonary edema● Angina pectoris

Restenosis in target vessel after priorrenal stent

Note if the indication for the current procedure is restenosis in the target renal artery that was previouslytreated with angioplasty and/or a stent.

● Renal artery restenosis is defined as �50% diameter stenosis at or adjacent to the site previouslytreated with balloon angioplasty or a stent.

Contrast volume Indicate the volume of iodinated contrast injected during the procedure in milliliters.

Fluoroscopy time Indicate the total fluoroscopy time recorded during the procedure to the nearest 0.10 min. The timerecorded should include the total time for the procedure.

Contralateral renal artery occlusion Indicate if there is known 100% occlusion of the patient’s contralateral renal artery.

Spontaneous aortic or renal arterydissection

Indicate if the patient has had a spontaneous renal artery dissection before the current procedure.

Procedure arterial access site Indicate the primary arterial access site used to perform the renal artery stenting procedure.

Note the location (right/left):● Femoral● Brachial● Radial● Axillary

Arterial access closure method ● List methods and devices in chronological order of closure.● Indicate the method used to achieve hemostasis:

— Device— Nondevice (such as manual compression)

Lesions

Target lesion location List the following:● Ostial● Proximal● Mid● Distal● Intrarenal

Visible thrombus present Indicate if the target lesion contains thrombus as assessed by baseline angiography and implied by thepresence of filling defect.



Lesion length Indicate the length of the target lesion in millimeters as assessed by baseline angiography.

Minimal luminal diameter Indicate the MLD of the target lesion in millimeters as assessed by baseline angiography.

Minimal luminal diameter is defined as the minimum luminal diameter derived from the angiographic viewthat shows the tightest point of the stenosis.

Diameter of distal renal artery Indicate the diameter of the nontapering distal segment of the renal artery measured at the intendedlanding zone of the distal edge of the stent.

Preprocedure percent stenosis ofrenal artery

Indicate the severity of stenosis by quantitative analysis using the formula


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Lesion treatment incomplete or aborted Indicate if the lesion treatment was incomplete or aborted. Choose 1 of the following:● Yes

— If yes, note the reasons:Œ Failure to gain vascular accessŒ Failure to engage ostium with guide catheterŒ Unable to cross with guidewireŒ Unable to deploy stentŒ Failure to confirm significant stenosisŒ Unable to cross balloonŒ Cardiac ischemiaŒ Unable to deploy deviceŒ HypotensionŒ HypertensionŒ Unable to deliver stentŒ Other

● No

Embolic protection attempted Indicate if the operator tried to use an EPD. Choose 1 of the following:● Yes

— If yes, indicate if predilatation before the balloon or stent was performed or not.— If yes, list EPD in chronological order. Note if successfully deployed.

● No

Stent malposition Indicate if the stent was deployed in a location or position other than that for which it was intended.

Final MLD Indicate the final residual lumen diameter in millimeters.

Final percent stenosis of renal artery Indicate the percent stenosis post procedure by quantitative analysis using the formula


Device

Number of stents used (per artery) ● 1● �1

Stent type Indicate the type of stent used. Choose all that apply:● Balloon expandable● Self-expanding● Drug eluting● Covered

Stent brand name Indicate the brand name of the stent used.

Stent model Indicate the model number of the stent used.

Stent manufacturer Indicate the manufacturer of the stent used.

Stent length Indicate the length of the stent used in millimeters.

Stent diameter Indicate the diameter of the stent used in millimeters.

Renal Artery Surgical Revascularization


Indications for the procedure Consider indications for renal artery revascularization. Choose all that apply:● Clinical indications

— Hypertension— Renal insufficiency— CHF/pulmonary edema— Angina pectoris

● Surgery-specific indications— Repetitive failure of renal artery angioplasty/stent— Need for aortic surgery (i.e., AAA repair)

Surgical procedures Indicate the surgical revascularization procedure:● Renal artery endarterectomy● Aortorenal bypass with either saphenous vein or synthetic material● Extra-anatomic bypass: hepatorenal, splenorenal, ileorenal

tcomes of Endovascular/en Surgical Procedures

Time points Indicate the period at which outcome measures are assessed. Choose all that apply:● Periprocedure (24 h)● Procedure related (30 d)● 3 mo

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● 6 mo● 1 y

Complications of endovascular procedure Indicate postoperative clinical events or conditions associated with the endovascular procedure.Choose all that apply:● Pseudoaneurysm● AV fistula● Hematoma● Dissection● Vessel thrombosis● Vessel perforation● Atheromatous embolization● Contrast nephropathy● Contrast hypersensitivity● Requirement of intervention to prevent permanent impairment/damage● Other (specify)● None

Complications of open surgery Indicate complications of open surgery. Choose all that apply:● Major complication


Œ Prolonged hospitalizationŒ Loss of limb or function of organ systemŒ Persistent or significant disability or incapacityŒ Vessel thrombosisŒ Vessel rupture


— Other life-threatening major complication (specify)Œ SeromaŒ HematomaŒ Mesenteric ischemiaŒ Renal failureŒ PneumoniaŒ Atheromatous embolizationŒ DVTŒ Graft thrombosisŒ Atheromatous embolizationŒ Contrast nephropathyŒ Contrast hypersensitivityŒ InfectionŒ Requirement for intervention to prevent permanent impairment/damage

— Minor complication (specify)

Total length of stay Indicate the length of stay in the hospital in number of days.

Discharge status Indicate the patient’s discharge status. Choose 1 of the following:● Discharged to home or self-care

— This includes discharge to home; jail or law enforcement; home on oxygen if DME only; any otherDME only; group home, foster care, and other residential care arrangements; outpatient programssuch as partial hospitalization or outpatient chemical dependency programs; assisted living facilitiesthat are not state designated.

● Discharged/transferred to short-term general hospital for inpatient care● Discharged/transferred to SNF with Medicare certification in anticipation of skilled care● Discharged/transferred to ICF● Discharged/transferred to standard rehabilitation facility● Discharged/transferred to ventilator rehabilitation facility● Discharged/transferred to another type of healthcare institution other than the above● Patient died



Recognition of new or worsening symptoms Verbal and written instructions provided to patient and/or family (by physician or nurse) regarding new orworsening symptoms and when to call the physician

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tery disease include thrombosis, embolism, and fibromus-lar dysplasia. Mesenteric artery disease refers to athero-lerotic stenosis or occlusion of the celiac trunk, superioresenteric artery, and/or inferior mesenteric artery. Otheruses include thrombosis, embolism, vasculitis, and extrin-c compression. The data elements defined in Table 4 includemptoms and clinical findings that occur in patients withnal artery disease. Table 4 also provides detailed elements

renal imaging tests, including duplex ultrasonography,

ble 4. Continued


Diet counseling Advice given or discussiocardiovascular risk. May● Sodium restriction● Fluid restriction● Referral to dietitian for● Other (specify)

Smoking cessation counseling Advice given or discussioof stopping smoking. Ma● Counseling (may be ba● Written materials● Referral to smoking ce● Drugs to help with sm

Activity counseling Advice given or discussioand/or exercise recomme

llow-Up

Open repair Documentation of evalua● Physical examination● Imaging (e.g., ultrasou

Endovascular Documentation of evalua● Physical examination● Imaging (e.g., ultrasou

inical Outcomes

Time points Indicate the period at wh● 1 mo● 3 mo● 6 mo● 1 y

Blood pressure ● Indicate systolic and d● Categories of blood pr

— Reduction in systoli— Reduction in diastol— Normotensive versu

● Indicate changes in th

nal function Monitor creatinine and es● Improvement: Change● Stable: No change in s● Decline: Change for th

orbidity/mortality ● MI● CHF● Stroke● Other adverse cardiov● Hospitalization/prolong● Loss of function of org● Persistent or significan● Death (indicate causes

AAA indicates abdominal aortic aneurysm; AV, atrioventricular; CHF, congestiep venous thrombosis; eGFR, estimated glomerular filtration rate; EPD, embolictermediate care facility; IDE, investigational device exemption; MDRD, modificatR, magnetic resonance; PAD, peripheral artery disease; and SNF, skilled nurs

agnetic resonance angiography, computed tomographic an- di

ography, and catheter-based angiography, In addition, theree detailed data elements for renal artery angioplasty andenting, including specific elements concerning the proce-re, target lesion location, results and complications, and

milarly for surgical revascularization of renal artery steno-s. In addition, data elements are defined for clinical out-mes following medical and revascularization therapy. Theta elements defined in Table 5 include symptoms andinical findings that occur in patients with mesenteric artery

ith the patient and/or family about diet counseling in relation to lowering

management and/or advanced nutritional instruction

ith patient (by physician, nurse, or other personnel) about the importanceedvanced)

programessation

ith patient and/or family about activity level and restrictions in activitys

he patient after discharge. Indicate all of the following that apply:

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he patient after discharge. Indicate all of the following that apply:

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ome measures are assessed. Choose all that apply:

blood pressure

pressure by 20 mm Hgpressure by 10 mm Hg

ensiveer of antihypertensive medications (specify medications)

/calculated GFR:ast 1 stage for the better (e.g., going from stage 3 to stage 2)

of at least 1 stage (e.g., going from stage 3 to stage 4)

eventitalizationemlity or incapacity

failure; CT, computed tomography; DME, durable medical equipment; DVT,ion device; FMD, fibromuscular dysplasia; GFR, glomerular filtration rate; ICF,et in renal disease; MI, myocardial infarction; MLD, minimal luminal diameter;lity.

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Risk Factors

Atherosclerosis Known atherosclerosis in any vascular territory

Patient Assessment: Symptoms

Indicate if any of the symptomslisted below are present

Symptoms suggestive ofmesenteric ischemia

● Abdominal fullness, bloating, discomfort after eating that ultimately results in “fear of food”● Weight loss, anorexia, failure to thrive● All associated with presence of atherosclerosis in other vascular beds or the presence of cardiac dysrhythmia

(i.e., atrial fibrillation) or severe left ventricular dysfunction

Postprandial abdominal pain Pain, bloating, early satiety following ingestion of food and/or liquids

Fear of eating Avoidance of eating because of predictable abdominal pain, often resulting in more frequent eating of smallamounts of food

Weight loss Specify amount of weight loss in pounds or kilograms.

Malnutrition The patient manifests malnutrition because of inadequate caloric intake to meet metabolic demands, as well asdehydration.

Malabsorption/steatorrhea ● Diarrhea● Oily stool● Floating stool

ysical Examination

Complete Abdominal Examination

Body habitus Describe the patient’s body habitus. Choose one of the following:● Thin● Normal● Obese

Aortic diameter Estimate abdominal aortic diameter by palpation in inches or centimeters.

Abdominal bruit Indicate the absence or presence of abdominal bruit. Choose 1 of the following:● Absent● Present

Rectal Exam

Digital rectal examination Examine the lower rectum to check for abnormalities in the rectum and stool (hemoccult).

Stool testing for occult blood Occult blood present or absent?

boratory Testing

Amylase, lipase Indicate the following:● Date of test● Value● Unit of measurement● Normal range

Stool fat content ● Microscopic: Indicate the number of stainable lipid globules per high-powered microscope field.● Gravimetric: Indicate the collection period (number of days), reference range, and test result in grams of lipid

per 24 h.● Titrimetric

Fecal occult blood Occult blood present or absent?

ninvasive Diagnostic Procedures

Mesenteric Artery Duplex Ultrasound



Peak systolic velocity measurements ● Aorta● Celiac artery● Superior mesenteric artery● Inferior mesenteric artery

Ratio of mesenteric artery to aortapeak systolic velocities

Record ratio for celiac, superior mesenteric, and inferior mesenteric arteries.

Location of stenosis Indicate the location of the stenosis. Choose all that apply:● Celiac artery● Superior mesenteric artery● Inferior mesenteric artery

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Category of stenosis Specify for celiac, superior mesenteric, and inferior mesenteric arteries. Choose 1 of the following:● 0–69%● 70%–99%● Occlusion

Computed Tomographic Angiography




Contrast volume Indicate volume of contrast used in milliliters.

Artery imaged Indicate artery imaged. Choose all that apply:● Celiac artery● Superior mesenteric artery● Inferior mesenteric artery

Location of stenosis Indicate the location of the stenosis.



Aneurysm Dilation of a mesenteric artery to a diameter �1.5 times the nondilated diameter

Small and large bowel Indicate if there is thickening of the small or large bowel wall. Choose 1 of the following:● Yes● No

Free air in the abdomen Indicate the presence of free air in the abdomen. Choose 1 of the following:● Yes● No

Mesenteric venous thrombosis Patent venous opacification of the superior mesenteric vein and portal vein

Pneumatosis coli Indicate the presence of pneumatosis coli:● Yes● No




Artery imaged Indicate the artery imaged. Choose all that apply:● Celiac artery● Superior mesenteric artery● Inferior mesenteric artery

Location of stenosis Indicate the location of the stenosis.




Small and large bowel Indicate if there is thickening of the small or large bowel wall. Choose 1 of the following:● Yes● No

Free air in the abdomen Indicate the presence of free air in the abdomen. Choose 1 of the following:● Yes● No

Mesenteric venous thrombosis Patent venous opacification of the superior mesenteric vein and portal vein

Pneumatosis coli Indicate the presence of pneumatosis coli:● Yes● No

agnostic Procedure: Invasive

Catheter-Based Angiography



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Artery imaged Indicate the artery imaged. Choose all that apply:● Celiac artery● Superior mesenteric artery● Inferior mesenteric artery




Diffuse vasospasm Indicate the presence or absence of vasospasm consistent with nonocclusive mesenteric ischemia.

Mesenteric venous thrombosis Indicate whether the superior mesenteric vein and portal vein are patent or occluded by thrombus.

vasive Therapeutic Procedures:theter Based

Mesenteric Artery Angioplasty Stenting



Angioplasty/stenting Choose one:● Balloon angioplasty alone● Stent

Balloon length Indicate the length of balloon used in millimeters.

Nominal balloon diameter Indicate the diameter of the balloon at initial inflation and final inflation in millimeters.

How many stents used (per artery)? ● 1● �1

Stent type Indicate type of stent used. Choose all that apply:● Balloon expandable● Self-expanding● Drug eluting● Covered

Stent brand name Identify the brand name of the stent used.

Stent model Identify the model number of the stent used.

Stent manufacturer Identify the manufacturer of the stent used.

Stent length Indicate the length of the stent used in millimeters.

Stent diameter Indicate the diameter of the stent used in millimeters.

Target mesenteric artery Indicate whether the target vessel for the procedure is the celiac, superior mesenteric, and/orinferior mesenteric artery.

Current procedure part of clinical trial Indicate whether the procedure is part of a clinical trial. Choose 1 of the following:● Yes

— If yes, indicate the trial type:Œ IDEŒ Postmarket approvalŒ Other (specify)

● No

Anesthesia Indicate if the patient received general anesthesia, conscious sedation, local anesthesia, or no anesthesia duringthe current procedure.


Clinical indication ● Symptoms of mesenteric ischemia● Weight loss● Malnutrition● Other

Restenosis in target vessel after priormesenteric artery stent

Note if the indication for the current procedure is restenosis in the target mesenteric artery that was previouslytreated with angioplasty and/or a stent.


Fluoroscopy time Indicate the total fluoroscopy time recorded during the procedure to the nearest 0.10 min. The time recordedshould include the total time for the procedure.

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Procedure arterial access site Indicate the primary arterial access site used to perform the mesenteric artery stenting procedure.

Note the location (right/left):● Femoral● Brachial● Radial● Axillary

Arterial access closure method ● List methods and devices in chronological order of closure.● Indicate the method used to achieve hemostasis:

— Device— Nondevice (such as manual compression)

Lesions

Target lesion location Indicate the location of the target lesion.

Visible thrombus present Indicate if the target lesion contains thrombus as assessed by baseline angiography and implied by the presenceof filling defect.

Calcification Indicate if calcification is present. If present, specify the location. Choose 1of the following:● None● Mild● Moderate● Severe


Minimal luminal diameter Indicate the MLD of the target lesion in millimeters as assessed by baseline angiography.

Diameter of distal mesenteric artery Indicate the diameter of the nontapering distal segment of the mesenteric artery measurement at the intendedlanding zone of the distal edge of the stent.

Preprocedure percent stenosis ofmesenteric artery



Lesion treatment incomplete oraborted

Indicate if the lesion treatment was incomplete or aborted. Choose 1 of the following:● Yes

— If yes, note reasons:Œ Failure to gain vascular access.Œ Failure to engage ostium with guide catheterŒ Unable to cross with guidewireŒ Unable to deploy stentŒ Failure to confirm significant stenosisŒ Unable to cross balloonŒ Cardiac ischemiaŒ Unable to deploy deviceŒ HypotensionŒ HypertensionŒ Unable to deliver stentŒ Other

● No

Embolic protection attempted Indicate if the operator tried to use an EPD:● Yes

— If yes, indicate if predilatation before balloon or stent was performed or not.— If yes, list EPD in chronological order. Note if successfully deployed.

● No

Stent malposition Indicate if the stent was deployed in a location or position other than that for which it was intended.

Final minimal luminal diameter Indicate the final residual lumen diameter in millimeters.

Final percent stenosis ofmesenteric artery



How many stents used (per artery)? ● 1● �1

vasive Therapeutic Procedure:rgical Revascularization

Aortomesenteric Bypass Graft Surgery


Proximal anastomosis Indicate the location of proximal anastomosis with graft (i.e., supraceliac aorta, iliac artery).

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Distal anastomosis Indicate the location of distal anastomosis with graft (i.e., mid-celiac artery, mid-SMA).

Conduit Indicate the type of graft material used for bypass (e.g., synthetic, autologous).

Mesenteric Endarterectomy


Outcomes of Endovascular/Open Surgery Procedures

Time points Indicate the period at which outcome measures are assessed. Choose all that apply:● Periprocedure (24 h)● Procedure related (30 d)● 3 mo● 6 mo● 1 y

Complications of endovascularprocedure

Indicate postoperative clinical events or conditions associated with an endovascular procedure.Choose all that apply:● Pseudoaneurysm● AV fistula● Hematoma● Dissection● Vessel thrombosis● Vessel perforation● Atheromatous embolization● Contrast nephropathy● Contrast hypersensitivity● Infection● Requirement of intervention to prevent permanent impairment/damage

Complications of open surgery Indicate complications of open surgery. Choose all that apply:● Major complication:

— Death— MI (also see cardiovascular complications below)— Stroke (ischemic, hemorrhagic, unknown type)

● Other life-threatening major complication (specify):— Prolonged hospitalization— Persistent or significant disability or incapacity— Vessel thrombosis— Vessel rupture— Seroma— Hematoma— Renal failure— Bowel infarction— Other end-organ damage— Pneumonia— DVT— Graft thrombosis— Atheromatous embolization— Requirement of intervention to prevent permanent impairment/damage— Infection


Total length of stay Indicate the length of stay in the hospital in number of days.

Discharge status Indicate the patient’s discharge status. Choose 1 of the following:● Discharged to home or self-care

— This includes discharge to home; jail or law enforcement; home on oxygen if DME only; any other DMEonly; group home, foster care, and other residential care arrangements; outpatient programs such as partialhospitalization or outpatient chemical dependency programs; assisted living facilities that are not statedesignated.

● Discharged/transferred to short-term general hospital for inpatient care● Discharged/transferred to an SNF with Medicare certification in anticipation of skilled care● Discharged/transferred to an ICF● Discharged/transferred to standard rehabilitation facility● Discharged/transferred to ventilator rehabilitation facility● Discharged/transferred to another type of healthcare institution other than the above● Patient died

(Continued)

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tery imaging tests, including duplex ultrasonography,agnetic resonance angiography, computed tomographicgiography, and catheter-based angiography. In addition,ere are detailed data elements for mesenteric arterygioplasty and stenting, including specific elements con-rning the procedure, target lesion location, results andmplications, and similarly for surgical revascularizationmesenteric artery disease. In addition, data elements arefined for clinical outcomes following medical and revas-

ble 5. Continued


Patient Education/Counseling

Medication instruction Verbal and written medication

Recognition of new or worseningsymptoms

Verbal and written instructionsworsening symptoms and whe

Diet counseling Advice given or discussion heldcardiovascular risk. May includ● Sodium restriction● Fluid restriction● Referral to dietitian for weig● Other (specify)

Smoking cessation counseling Advice given or discussion heldstopping smoking. May include● Counseling (may be basic or● Written materials● Referral to smoking cessatio● Drugs to help with smoking

Activity counseling Advice given or discussion heldexercise recommendations

Follow-Up

Open repair Documentation of evaluation of● Physical examination● Imaging (e.g., ultrasound, M

Endovascular Documentation of evaluation of● Physical examination● Imaging (e.g., ultrasound, M

inical Outcomes

Time points Indicate the period at which ou● 1 mo● 3 mo● 6 mo● 1 y

Patient assessment Assess recurrent signs and sym● Appetite● Caloric intake● Nutritional status● Presence or absence of pos● Food avoidance/tolerance● Weight loss/gain

Adverse events ● Recurrent bowel ischemia/in● Repeat revascularization● Bowel resection● MI● Stroke (ischemic, hemorrhag● Other adverse event● Death

AV indicates atrioventricular; CT, computed tomography; DME, durable meditermediate care facility; IDE, investigational device exemption; MI, myocardialesenteric artery; and SNF, skilled nursing facility.

larization therapy. ar

.5. Extracranial Carotid and Vertebral Arteryisease Table of Data Elements

the context of this document, extracranial carotid arterysease is defined as a cerebral artery atherosclerotic diseaseat causes stenosis or occlusion of the cervical portion of therotid arteries (2). Other causes of carotid artery diseaseclude fibromuscular dysplasia, arteritis, radiation-inducedteriopathy, dissection, and restenosis following carotid

ons provided to patient and/or family

d to patient and/or family (by physician or nurse) regarding new orthe physician

atient and/or family about diet counseling in relation to lowering

gement and/or advanced nutritional instruction.

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ed)

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atient and/or family about activity level and restrictions in activity and/or

following discharge. Indicate all of the following that apply:

after discharge. Indicate all of the following that apply

easures are assessed. Choose all that apply:

of mesenteric disease:

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pment; DVT, deep venous thrombosis; EPD, embolic protection device; ICF,n; MLD, minimal luminal diameter; MR, magnetic resonance; SMA, superior

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tient History

Asymptomatic Indicate if the patient is asymptomatic. No prior stroke or TIA

Symptomatic Indicate the onset and duration of symptoms.

Previous stroke Previous stroke is defined as an acute loss of neurological function caused by an ischemic or hemorrhagicevent with residual symptoms for at least 24 h or symptoms for �24 h with evidence of acute infarction (e.g.,by CT or MRI).

If present, record stroke type:● Ischemic● Intracerebral hemorrhage● Subarachnoid hemorrhage● Unknown

If ischemic, list the most likely etiologies:● Large-artery atherosclerosis of the extracranial vessels (e.g., carotid)● Large-artery atherosclerosis of the intracranial vessels (e.g., middle cerebral artery stenosis)● Cardioembolism● Small-vessel occlusion (lacunar)● Ischemic stroke of other determined etiology (e.g., arterial dissection)● Ischemic stroke of undetermined etiology

Transient ischemic attack (TIA) Documented history of TIA consisting of a transient episode of neurological dysfunction caused by focal brain,spinal cord, or retinal ischemia, without acute infarction

Note the following:● Right retinal● Right hemispheric● Left retinal● Left hemispheric● Vertebrobasilar● Unknown distribution

Date of first and most recent episode

ASA grade Choose 1 of the following:● Grade I: Normal, healthy● Grade II: Mild systemic disease that does not limit activity● Grade III: Severe systemic disease that limits activity but is not incapacitating● Grade IV: Incapacitating systemic disease that is constantly life threatening● Grade V: Moribund; not expected to survive 24 h with or without surgery

History of dementia History of dementia, Alzheimer’s disease, chronic confusion (at least 1 mo in duration), or senility


Seizures Indicate if the patient has a documented history of epilepsy.

Hemorrhage Indicate if the patient has a hemorrhage. Choose all that apply:● Intraparenchymal● Intraventricular● Subarachnoid● Subdural

Cause of carotid/vertebral stenosis Select any of the following that apply● Atherosclerosis● FMD● Dissection● Vasculitis (Takayasu’s or giant cell arteritis)● Irradiation● Restenosis following CEA● Restenosis following CAS● Restenosis following vertebral angioplasty/stenting

atomic High-Risk Conditions

Previous neck radiation Indicate if the patient had previous radiation therapy to the neck before the current admission or procedure.

Previous neck surgery(other than CEA)

Indicate if the patient had a previous extensive (i.e., radical) neck dissection (other than CEA) before thecurrent admission or procedure.

Previous carotid intervention Yes or no. If yes, within �30 d, 31–180 d, or �180 d?

Note:● Right CEA● Right CAS● Left CEA● Left CAS

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Previous vertebral intervention Yes or no. If yes, within �30 d, 31–180 d, or �180 d?

Note:● Left● Right● Proximal● Distal

Previous ipsilateral CEA Yes or no

Tracheostomy present Indicate if the patient has an open tracheostomy at the time of the current procedure.

Cranial nerve palsy (32,33) Indicate if patient has a history of cranial nerve palsy/palsies. Choose 1 of the following:● Yes

— If yes, indicate all nerves involved:Œ Recurrent laryngeal or its parent nerve, the vagus nerveŒ HypoglossalŒ FacialŒ Other

● No

morbid Cardiopulmonarynditions

History of chronic lung disease History of chronic lung disease (e.g., chronic obstructive pulmonary disease, chronic bronchitis, emphysema, restrictivelung disease) or currently receiving long-term treatment with inhaled or oral pharmacological therapy (e.g.,beta-adrenergic agonist, anti-inflammatory agent, leukotriene receptor antagonist, or steroid)


On home oxygen Indicate if, before the current procedure, the patient has been receiving home oxygen therapy for treatment of chroniclung disease.

NYHA class III or IV in last 6 wk Indicate if the patient’s highest NYHA cardiac functional class has been class III or IV at any time within 6 wk before thecurrent procedure. Patients in NYHA classes III and IV have anginal or heart failure symptoms at rest and/or resulting inmarked limitation of physical activity. NYHA classes III and IV are formally defined as follows:● Class III: Patient has cardiac disease resulting in marked limitation of physical activity. Patient is comfortable at rest.

However, less than ordinary physical activity (e.g., walking 1 to 2 level blocks or climbing 1 flight of stairs) causesfatigue, palpitations, dyspnea, or anginal pain.

● Class IV: Patient has dyspnea at rest that increases with any physical activity. Patient has cardiac disease resulting ininability to perform any physical activity without discomfort. Symptoms may be present even at rest. If any physicalactivity is undertaken, discomfort is increased.

Note: For patients without cardiac disease or patients with NYHA class I or II, code No.

tient Assessment

Carotid bruits Indicate if carotid bruits are present. Choose 1 of the following:● Yes

— Left— Right— Bilateral

● No● Not assessed

Supraclavicular bruits Indicate if supraclavicular bruits are present. Choose 1 of the following:● Yes

— Left— Right— Bilateral

● No● Not assessed

NIH Stroke Scale score Indicate if the NIHSS was used. Choose 1 of the following:● Yes

— Indicate scores done before the procedure, immediately after the procedure, before discharge, and other.● No

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Modified Rankin Stroke Scalescore

Indicate the patient’s score:

Score Description

0 No symptoms at all

1 No significant disability despite symptoms; able to carry out all usual duties and activities

2 Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance

3 Moderate disability; requiring some help but able to walk without assistance

4 Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needswithout assistance

5 Severe disability; bedridden, incontinent, and requiring constant nursing care and attention

6 Death

Barthel Index Indicate if the Barthel Index was measured. Choose 1 of the following:● Yes

— Indicate scores done before the procedure, immediately after the procedure, before discharge, and other.● No

Specific neurologic findings Indicate the presence or absence of the following:● Hemiparesis● Upper motor neuron facial weakness● Lower motor neuron facial weakness● Dysphasia● Hemisensory loss● Visuospatial neglect● Branch retinal artery occlusion● Central retinal artery occlusion● Dysarthria● Gait ataxia● Disconjugate gaze● Tongue deviation● Nystagmus

agnostic Procedures

Carotid Duplex Ultrasound


Location of measurement Measure each of the following in the right CCA, right ICA, left CCA, and left ICA.

Plaque characteristics Indicate if any of the following are present:● No plaque● Homogeneous plaque (stable)● Heterogeneous plaque (unstable)● Surface irregularity

Intima-media thickness Indicate intima-media thickness in millimeters.

CCA systolic velocity Measure systolic velocity in proximal, mid, and distal segments of CCA.

Measure velocity in centimeters per second.

CCA diastolic velocity Measure diastolic velocity in proximal, mid, and distal segments of CCA.


ICA systolic velocity Measure systolic velocity in proximal, mid, and distal segments of ICA.


ICA diastolic velocity Measure diastolic velocity in proximal, mid, and distal segments of ICA.


Peak ICA: distal CCA systolicvelocity ratio

Indicate systolic velocity radio measured in centimeters per second. Choose 1 of the following:● �2.0● 2.0–4.0● �4.0

Degree of stenosis Indicate range of stenosis:● Normal● 1%–49%● 50%–69%● 70%–99%● Complete occlusion

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Carotid stent stenosis Indicate the range of stenosis after carotid stenting:● Normal● 1%–49%● 50%–69%● 70%–99%● Complete occlusion

Carotid bifurcation location Indicate the location of carotid bifurcation. Choose 1 of the following:● Normal● High

Vertebral artery flow direction Indicate the direction of artery flow for the right and left vertebral artery. Choose 1 of the following:● Forward● Reversed● No flow detected

CT Angiography


Radiologist Last name, first, middle


Luminal diameter of CCA Measure diameter in millimeters.

Luminal diameter of ICA Measure diameter in millimeters.

Degree of stenosis Use the NASCET method for measurement of stenosis defined by the formula

% stenosis�100�(1�minimum luminal diameter at the lesion site)/diameter of nontapering segment of distal ICA

Nonobstructed diameter of ICA Measure diameter in millimeters.

Plaque characteristics Indicate if any of the following are present:● Calcifications● Ulceration● Tandem lesion

Intracranial atheroscleroticdisease

Indicate if intracranial atherosclerotic disease (�50% stenosis) is present in the distribution in either the right or leftICAs: Yes or no.

Other vascular abnormality Indicate if another vascular abnormality is present, including aneurysm, AVM, etc.




Diameter of CCA Measure diameter in millimeters.

Diameter of ICA Measure diameter in millimeters.

Degree of stenosis Use the NASCET method for measurement of stenosis defined by the formula

% stenosis�100�(1�minimum luminal diameter at the lesion site)/diameter of nontapering segment of distal ICA

Nonobstructed diameter of ICA Measure diameter in millimeters.

Plaque Indicate if any of the following are present and describe:● Fibrous cap thickness in millimeters● Fibrous cap disruption● Intraplaque lipid content● Intraplaque hemorrhage

Tandem lesion Indicate yes or no.

Other vascular abnormality Indicate if another vascular abnormality is present, including aneurysm, AVM, etc.

Intracranial atheroscleroticdisease

Indicate if intracranial atherosclerotic disease (�50% stenosis) is present in the distribution of either the right or left ICA:Yes or no.

vasive Therapeutic Procedures:rotid and Vertebral Artery Stenting


Target carotid vessel Indicate whether the target vessel is the right or left carotid artery for the current procedure: Right or left.

Target vertebral artery Indicate whether the target vessel is the right or left vertebral artery for the current procedure: Right or left.

Is the current procedure part of aclinical trial?

Yes or no. If yes, note trial type:● Postmarket surveillance● Premarket approval● IDE● Other (specify)

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Anesthesia Indicate if the patient received general anesthesia, local anesthesia, or no anesthesia during the current procedure. If�1 method was used, code it General.


Target lesion symptomaticwithin past 6 mo

Indicate if the patient has had neurologic symptoms related to the target lesion in the past 6 mo.

Restenosis in target vesselafter prior CAS

Note if the indication for the current procedure is restenosis in the target carotid artery that was previously treated withangioplasty and/or a stent. Carotid artery restenosis is defined as �50% diameter stenosis at or adjacent to the sitepreviously treated with balloon angioplasty or a stent.

Restenosis of target vesselafter prior CEA

Note if the indication for the current procedure is restenosis in the target carotid artery that was previously treated withcarotid artery endarterectomy. Restenosis is defined as renarrowing within or adjacent to a prior endarterectomy site,evidenced by �50% diameter stenosis.

Carotid lesion difficult to accesssurgically

Indicate if the lesion is difficult to access surgically for CEA.Yes or noNote: Lesions that are difficult to access include those that are high in the neck (e.g., at or above the level of C2) andthose that are within the proximal one half or one third of the CCA, at or below the clavicle, rendering endarterectomyeither difficult or impossible.

Vertebral lesion difficult toaccess surgically

Indicate if the lesion is difficult to access surgically.Yes or no

Aortic arch type Indicate the patient’s aortic arch type configuration. The 3 types of aortic arch are based on the relationship of theinnominate artery to the aortic arch. The more inferior the origin of the target artery (i.e., type II or III aortic arch), thegreater the difficulty in gaining access to the carotid artery.

Category:● Type I● Type II● Type III


Fluoroscopy time Indicate the total fluoroscopy time recorded during the procedure to the nearest 0.10 min. The time recorded shouldinclude the total time for the procedure.

Contralateral carotid occlusion Indicate if there is known 100% occlusion of the patient’s contralateral carotid artery.

Contralateral vertebral occlusion Indicate if there is known 100% occlusion of the patient’s contralateral vertebral artery.

Bovine arch Indicate if the patient’s aortic arch is bovine, in which the right brachiocephalic and left carotid arteries share a commontrunk from the aortic arch.

Procedure arterial access site Indicate the primary arterial access site used to perform the CAS procedure.

Note the location:● Femoral● Direct carotid puncture● Direct vertebral puncture● Brachial● Radial● Axillary exposure● Carotid cut down● Vertebral cut down

Arterial access closure method List methods and devices in chronological order of closure. Indicate the method used to achieve hemostasis. Methodsshould include devices and nondevices such as manual compression.

Tandem lesions Indicate if there is evidence of tandem lesions. Choose 1 of the following:● Yes

— Specify location(s)● No

Intracranial stenosis Indicate if there is evidence of intracranial lesions. Choose 1 of the following:● Yes

— Specify location(s)● No

Other intracranial pathology Indicate if there is evidence of other intracranial pathology. Choose 1 of the following:● Yes

— Specify type● No

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Lesions and Devices

Target lesion location List the following:● Isolated CCA● Isolated ICA● Bifurcation● Vertebral ostia● Vertebral artery ostia● Midcervical vertebral

Visible thrombus present Indicate if the target lesion contains thrombus as assessed by baseline angiography and implied by the presence offilling defect.

Ulceration Indicate if the target lesion is ulcerated as assessed by baseline angiography.




Minimal luminal diameter Indicate the MLD of the target lesion in millimeters as assessed by baseline angiography. The MLD is defined as theminimum luminal diameter derived from the angiographic view that shows the tightest point of the stenosis.

Diameter of distal ICA Indicate the diameter of the nontapering distal segment of the ICA for NASCET measurement at the intended landingzone of the distal edge of the stent (where the vessel is no longer tapered and the walls become parallel).

Note: NASCET was a randomized clinical trial that compared the safety and efficacy of CEA to medical therapy for theprevention of stroke in symptomatic patients.

Preprocedure percent stenosisof the carotid artery

Indicate the percent stenosis preprocedure, which is calculated as follows:1. When the tightest stenosis is in the ICA or at the carotid bifurcation, use the NASCET method. Percent diameter

stenosis is calculated as 1�(minimum luminal diameter at the lesion site/diameter of nontapering segment of thedistal ICA). The nontapering site is where the walls of the ICA become parallel.

2. Do not use the NASCET method if the distal lumen collapses from a low-flow situation. In such cases, enter 99%because the stenosis may be graded as a near-occlusion.

3. For stenosis localized to the CCA, percent diameter stenosis is calculated as 1�(minimum luminal diameter/diameterof the adjacent normal segment of the CCA).

Preprocedure percent stenosisof the vertebral artery

Indicate preprocedure percent stenosis calculated as follows:

When the tightest stenosis is in the cervical vertebral artery (origin to dural entry), percent diameter stenosis iscalculated as 1�(minimum luminal diameter of the nontapering segment of the distal vertebral artery). The nontaperingsite is where the walls of the vertebral artery become parallel.

Lesion treatment incomplete oraborted

Indicate if the lesion treatment was incomplete or aborted: Yes or no. If yes, note the reason(s):● Failure to gain vascular access● Unable to cross with guidewire● Unable to cross with balloon● Unable to deploy stent● Arrhythmia● Failure to confirm significant stenosis● Difficult to access because of tortuosity● Cardiac ischemia● Hypotension● Hypertension● Unable to deliver stent● Acute neurological event● Other

Embolic protection attempted Indicate if the operator tried to use an EPD:● Yes— Indicate if predilatation was done before balloon or stent.— List EPD devices in chronological order.— Note if successfully deployed.● No

If yes, indicate if predilatation was done before balloon or stent.● Yes● No

If yes, list EPD devices in chronological order.

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Predilatation Indicate if predilatation was performed before the attempted stent implantation or after EPD: Yes or no

Stents implanted Were stents implanted? Yes or no. If yes, list stents in chronological order with the following information:● Stent● Brand● Model● Manufacturer

Stents tapered Yes or no

Stent(s) diameter Indicate the diameter of the stent. If a tapered stent was used, indicate the smallest diameter of the tapered stent inmillimeters.

Stent(s) length Indicate the length of the stent in millimeters.

Stent(s) malposition Indicate if the stent was deployed in a location or position other than that for which it was intended.

Postdilatation performed Was postdilatation performed? Yes or no. If yes, note the following:● Nominal balloon diameter in millimeters● Maximum inflation pressure in atmospheres

Final MLD Indicate the final residual lumen diameter in millimeters.

Final percent stenosis forcarotid artery

Indicate percent stenosis postprocedure, calculated as follows:1. For an ICA site, use NASCET methodology. Percent diameter stenosis is calculated as 1�(minimum residual luminal

diameter within the treated site/diameter of the nontapering segment of the distal ICA). The nontapering site is wherethe walls of the ICA become parallel.

2. For a lesion and interventional site localized to the CCA, percent diameter stenosis is calculated as 1�(minimumresidual luminal diameter/diameter of the adjacent normal segment of the CCA).

Final percent stenosis forvertebral artery

Value is dependent on the largest stenosis using essentially similar NASCET criteria for vertebral disease.

vasive Therapeutic Procedures:rotid Endarterectomy



Is the current procedure part of acarotid trial?

Yes or no. If yes, note the type of trial:● Postmarket surveillance● Premarket approval● IDE● Other (specify)

Target carotid vessel Indicate whether the target vessel is the right or left carotid artery for the current procedure:● Right● Left● Common● Bifurcation● Distal internal

Anesthesia Indicate if the patient received general anesthesia, local anesthesia, or no anesthesia during the current procedure. If�1 method of anesthesia was given, code it General.

Endarterectomy technique Standard or eversion



Indicate if the patient has had neurologic symptoms related to the target lesion in the past 6 mo.


Yes or no

Target lesion symptomaticwithin past 6 wk

Yes or no

Restenosis in target vesselafter prior CEA

Note if the indication for the current procedure is restenosis in the target carotid artery that was previously treated withCEA. Restenosis is defined as renarrowing within or adjacent to a prior endarterectomy site, evidenced by �50%diameter stenosis.

Contralateral carotid arteryocclusion

Indicate if there is known 100% occlusion of the patient’s contralateral carotid artery.

Contralateral carotid arterystenosis

Yes or no

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Spontaneous carotid arterydissection

Indicate if the patient has had a spontaneous carotid artery dissection before the current procedure: Yes or no.

If yes, note the location:● Common carotid● Carotid bifurcation● Distal internal

Tandem lesions Yes or no. If yes, note the location.

Intracranial stenosis Yes or no. If yes, note the location.

Other intracranial pathology Yes or no. If yes, note the type.

Intraprocedural Information

Patch utilization Standard technique?● Yes

— If yes, indicate the type of patch (e.g., Dacron, PTFE, bovine pericardium, vein).● No

Thrombus present ondirect visual inspection

Indicate if a thrombus (blood clot) was present on direct visual inspection intraoperatively during the CEA procedure.

Monitoring technique used Note the following:● Awake monitoring● Selective monitoring based on EEG, stump pressure, SSEP, motor-evoked potential, anatomic, or other factor

(describe).

Shunting used Indicate if a shunt was used. If yes, note the following:● Selective shunt based on EEG, stump pressure, SSEP, motor-evoked potential, anatomic, or other factor (describe)● Was a shunt indicated but not technically possible?

Surgical procedure terminated Indicate if the CEA procedure was terminated: Yes or no. If yes, note the reason(s):● Hypotension● Hypertension● Nerve compromise● Excessive scar tissue● Carotid artery thrombosis● Difficulty with anesthesia● Difficulty with suction● ICA string sign or atresia● Cardiac instability● Inability to implement shunting● Excessive bleeding● Inability to access lesion because of anatomical lesions● Other (specify)

Intraoperative completionevaluation

Check all that apply:● None● Standard Doppler● Arteriogram (include findings)● Duplex scan (include findings)

Intraoperative complications Indicate any of the following:● Reopening of carotid artery (note indication and findings)● Technical difficulties (describe)

Patient outcome ● Normal neurologic exam● Deficit (describe)

Medications

Antiplatelet therapy, aspirin Yes or no. If yes, note type.

Contraindicated clopidogrel Yes or no

Contraindicated ticlopidine Yes or no

Contraindicated other Yes or no

Intraoperative anticoagulation Indicate the drug and dose used

ocedural Outcomes

Intraprocedural/intraoperativeadverse events

Indicate adverse event(s) that occurred during or after the procedure. Specify time of occurrence relative to procedure:● Abrupt closure● Spasm requiring treatment● Loss of external carotid● Distal intracranial embolization● Embolization (systemic)

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● Embolization (carotid)● Thrombosis● Occlusive untreated dissection● Arrhythmia requiring treatment● Hypotension requiring treatment● Hypertension requiring treatment● Stroke (ischemic, hemorrhagic, unknown type)● TIA● Amaurosis fugax● Seizure● Puncture site complications● Death (or death in lab)● Intubation or resuscitation● Stent malposition● Embolic protection retrieval● Intracranial hemorrhage● Other (specify)

Results ● Procedure technical failure—unable to deploy stent● Procedure terminated for stenosis �70%● Procedure terminated because of complication before deployment● Procedure technical success without complications● Procedure technical success with complications

Acute occlusion Indicate if there is acute occlusion �24 h after the procedure.

Residual stenosis Note:● Right● Left● Bilateral

Right-side percent stenosis Indicate right-side percent stenosis.

Left-side percent stenosis Indicate left-side percent stenosis.

Stent migration/deformation Stent located in planned landing zone with complete lesion coverage

Distal embolization Occlusion of cerebral arteries or periprocedural neurologic deficit resulting from dislodgment of atheromatous debris orthrombus from the procedural site

Postprocedural complications inhospital

Indicate if any of the following occurred:● None● Arrhythmia requiring treatment● Hypotension requiring treatment● Hypertension requiring treatment● MI● New unstable angina● Electrocardiographic changes● Cardiac enzyme elevations● Pulmonary embolism● Stroke (ischemic, hemorrhagic, unknown type)● Deterioration in Modified Rankin Scale score● TIA● Amaurosis fugax● Seizure● Intracranial hemorrhage● Hyperperfusion syndrome● Other neurologic complication (specify)● Secondary carotid intervention (specify)● Vessel thrombosis or ischemia of extremity● Puncture site complications● Pseudoaneurysm● Pseudoaneurysm vascular repair● Hematoma (local or retroperitoneal) (indicate if transfusion required)● Other bleeding (indicate if transfusion required)● Access site infection● Creatinine increase �1.0 mg/dL● Hemodialysis

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● Pneumonia● Urinary tract infection● Sepsis● Death● Other (specify)



Recognition of new orworsening symptoms

Verbal and written instructions provided to patient and/or family (by physician or nurse) regarding new or worseningsymptoms and when to call the physician

Diet counseling Advice given or discussion held with the patient and/or family about diet counseling related to loweringcardiovascular risk. May include● Sodium restriction● Fluid restriction● Other (specify)

Referral to dietician for dietcounseling

Referral to dietitian for weight management and/or advanced nutritional instruction

Activity counseling Advice given or discussion held with the patient and/or family about activity level and restrictions in activity and/orexercise recommendations.

Smoking cessation counseling Advice given or discussion held with the patient (by physician, nurse, or other personnel) about the importance ofstopping smoking. May include● Counseling (may be basic or advanced)● Written materials● Referral to smoking cessation program● Drugs to assist for smoking cessation

Plan for follow-up care Documentation of plan for follow-up care with physician and/or nurse

Should include date of follow-up

Patient referral Patient referred to other care such as neurology, neurosurgery, vascular surgery, cardiology clinic/office.

Transitional care (specify duration):● Home health care● Nurse case manager● Hospice or palliative care● Home telemonitoring● Ambulatory cardiac telemetric monitoring (e.g., mobile cardiac outpatient telemetry)● Period of time enrolled in the program and/or qualitative characterization of the level of the

patient’s success/participation in the program(s) may be specified.

Discharge status Indicate the following:● Discharge NIHSS score● Discharge Modified Rankin Scale score● Discharge Barthel Index● Cranial nerve injury● Technical defects requiring revision● Stroke (ischemic, hemorrhagic, unknown type)—note date● TIA (single or multiple)—note date● Amaurosis fugax● MI (Q wave or non–Q wave)—note date

tcomes

Time points Indicate the period at which outcome measures are assessed. Choose all that apply:● 1 mo● 3 mo● 6 mo● 1 y

Follow-up visit Documentation of follow-up evaluation for patients with established carotid/vertebral arterial disease should include● Patient history● Functional status● Physical examination● Laboratory or other tests

Date of visit Indicate the date of visit (mo/d/y).

Follow-up NIHSS (See scale above.)

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Repeat duplex ultrasoundperformed

Indicate if repeat duplex ultrasound was performed in any of the following time frames:● Before discharge

— Yes— No

● 3 mo— Yes— No


● Annually— Yes— No



MRA or CTA performed Indicate if MRA or CTA was performed in any of the following time frames:● Before discharge

— Yes— No



● Annually— Yes— No



Follow-up Modified Rankin Scalescore

(See scale above.)

Follow-up Barthel Index (See scale above.)

Stroke Indicate stroke type:● Ischemic● Hemorrhagic● Unknown

Indicate whether or not the patient was hospitalized.

Reason for termination Indicate the reason for termination.

Death Note the following:● Date● Cause● Date of the last visit in which the patient was evaluated● Death within 30 d of last visit● Death 30 d after last visit

Repeat Hospitalization

Date of admission Indicate the date of admission (mo/d/y).

Primary reason for readmission Stroke, TIA, MI, other

Repeat duplex ultrasoundperformed?

Yes or no



Was repeated MRA, CTA, orconventional angiogramperformed?

Yes or no

Target lesion revascularization Indicate whether CAS was performed.

Target vessel revascularization Indicate whether CEA or CAS was performed.

(Continued)

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d intracranial cerebral artery diseases are outside the scopethis document. The data elements defined in Table 6

clude symptoms and clinical findings related to ischemicrokes and transient ischemic attacks that occur in patientsith carotid artery disease. Also included are data elementsat define anatomic high-risk conditions and comorbid car-opulmonary conditions that are used to assess risk ofrotid revascularization procedures. Table 6 provides de-iled elements of carotid artery imaging tests, includingplex ultrasonography, magnetic resonance angiography,mputed tomographic angiography, and catheter-based an-ography. In addition, there are detailed data elements forrotid artery stenting, including specific elements concern-g the procedure, target lesion location, results and compli-tions, and similarly for carotid endarterectomy. In addition,ta elements are defined for clinical outcomes followingrotid revascularization.

taff

merican College of Cardiology Foundationhn C. Lewin, MD, Chief Executive Officerharlene May, Senior Director, Science and Clinical Policyelanie Shahriary, RN, BSN, Director, PerformanceMeasures and Data Standards

merican College of Cardiologyoundation/American Heart Associationaria Lizza D. Isler, BSMT, Specialist, Clinical DataStandards

merican Heart Associationancy Brown, Chief Executive Officerose Marie Robertson, MD, FACC, FAHA, Chief ScienceOfficer

ayle R. Whitman, PhD, RN, FAHA, FAAN, Senior VicePresident, Office of Science Operationsark D. Stewart, MPH, Science and Medicine Advisor,Office of Science Operationsdy Hundley, Production Manager, Scientific Publishing,Office of Science Operations

eferences. Health Insurance Portability and Accountability Act of 1996. Public Law

104-191. 1996.. Hiatt WR, Goldstone J, Smith SC Jr., et al. Atherosclerotic Peripheral

Vascular Disease Symposium II: nomenclature for vascular diseases.

ble 6. Continued


Stent patency Indicate whether the stent is patent an● Right-side percent stenosis● Left-side percent stenosis

ASA indicates American Society of Anesthesiologists; AVM, arteriovenous madarterectomy; CT, computed tomography; CTA, computed tomographic aromuscular dysplasia; ICA, internal carotid artery; IDE, investigational device esonance angiography; MRI, magnetic resonance imaging; NASCET, North AmHSS, National Institutes of Health Stroke Scale; NYHA, New York Heart Associansient ischemic attack.

Circulation. 2008;118:2826–9.

. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 guidelines forthe management of patients with peripheral arterial disease (lowerextremity, renal, mesenteric, and abdominal aortic): executive summary:a collaborative report from the American Association for VascularSurgery/Society for Vascular Surgery, Society for Cardiovascular An-giography and Interventions, Society for Vascular Medicine and Biology,Society of Interventional Radiology, and the ACC/AHA Task Force onPractice Guidelines (Writing Committee to Develop Guidelines for theManagement of Patients With Peripheral Arterial Disease). J Am CollCardiol. 2006;47:1239–312.

. Rooke T, Hirsch A, Misra S, et al. 2011 ACCF/AHA focused update ofthe guideline for the management of patients with peripheral arterydisease (updating the 2005 guideline): a report of the American Collegeof Cardiology Foundation/American Heart Association Task Force onPractice Guidelines. J Am Coll Cardiol. 2010;58:2020–45.

. Olin JW, Allie DE, Belkin M, et al. ACCF/AHA/ACR/SCAI/SIR/SVM/SVN/SVS 2010 performance measures for adults with peripheral arterydisease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures, theAmerican College of Radiology, the Society for Cardiac Angiographyand Interventions, the Society for Interventional Radiology, the Societyfor Vascular Medicine, the Society for Vascular Nursing, and the Societyfor Vascular Surgery (Writing Committee to Develop Clinical Perfor-mance Measures for Peripheral Artery Disease). J Am Coll Cardiol.2010;56:2147–81.

. Buxton AE, Calkins H, Callans DJ, et al. ACC/AHA/HRS 2006 key dataelements and definitions for electrophysiological studies and procedures:a report of the American College of Cardiology/American Heart Associ-ation Task Force on Clinical Data Standards (ACC/AHA/HRS WritingCommittee to Develop Data Standards on Electrophysiology). J Am CollCardiol. 2006;48:2360–98.

. Cannon CP, Battler A, Brindis RG, et al. American College of Cardiologykey data elements and definitions for measuring the clinical managementand outcomes of patients with acute coronary syndromes: a report of theAmerican College of Cardiology Task Force on Clinical Data Standards(Acute Coronary Syndromes Writing Committee). J Am Coll Cardiol.2001;38:2114–30.

. Hendel RC, Budoff MJ, Cardella JF, et al. ACC/AHA/ACR/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/SCCT/SCMR/SIR 2008 key data ele-ments and definitions for cardiac imaging: a report of the AmericanCollege of Cardiology/American Heart Association Task Force on Clin-ical Data Standards (Writing Committee to Develop Clinical DataStandards for Cardiac Imaging). J Am Coll Cardiol. 2009;53:91–124.

. McNamara RL, Brass LM, Drozda JP Jr, et al. ACC/AHA key dataelements and definitions for measuring the clinical management andoutcomes of patients with atrial fibrillation: a report of the AmericanCollege of Cardiology/American Heart Association Task Force on Clin-ical Data Standards (Writing Committee to Develop Data Standards onAtrial Fibrillation). J Am Coll Cardiol. 2004;44:475–95.

. Radford MJ, Arnold JM, Bennett SJ, et al. ACC/AHA key data elementsand definitions for measuring the clinical management and outcomes ofpatients with chronic heart failure: a report of the American College ofCardiology/American Heart Association Task Force on Clinical DataStandards (Writing Committee to Develop Heart Failure Clinical DataStandards). Circulation. 2005;112:1888–916.

. Weintraub WS, Karlsberg RP, Tcheng JE, et al. ACCF/AHA 2011 keydata elements and definitions of a base cardiovascular vocabulary for

enosis is present:

on; CAS, carotid artery stenting; CCA, common carotid artery; CEA, carotidhy; EEG, electroencephalogram; EPD, embolic protection device; FMD,

n; MI, myocardial infarction; MLD, minimal luminal diameter; MRA, magneticymptomatic Carotid Endarterectomy Trial; NIH, National Institutes of Health;FE, polytetrafluoroethylene; SSEP, somatosensory evoked potential; and TIA,

d if rest

lformatingiograpxemptioerican Stion; PT

electronic health records: a report of the American College of Cardiology

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Foundation/American Heart Association Task Force on Clinical DataStandards. J Am Coll Cardiol. 2011;58:202–22.

. National Cardiovascular Data Registry. Available at: http://www.ncdr.com/webncdr/common/. Last updated January 1, 2011. Accessed February 4, 2011.

. Radford MJ, Heidenreich PA, Bailey SR, et al. ACC/AHA 2007 meth-odology for the development of clinical data standards: a report of theAmerican College of Cardiology/American Heart Association Task Forceon Clinical Data Standards. J Am Coll Cardiol. 2007;49:830–7.

. Rundback JH, Sacks D, Kent KC, et al. Guidelines for the reporting ofrenal artery revascularization in clinical trials. Circulation. 2002;106:1572–85.

. Murphy TP, Hirsch AT, Ricotta JJ, et al. The Claudication: Exercise Vs.Endoluminal Revascularization (CLEVER) study: rationale and methods.J Vasc Surg. 2008;47:1356–63.

. Murphy TP, Hirsch AT, Cutlip DE, et al. Claudication: Exercise Vs.Endoluminal Revascularization (CLEVER) study update. J Vasc Surg.2009;50:942–5.

. Cooper CJ, Murphy TP, Matsumoto A, et al. Stent revascularization forthe prevention of cardiovascular and renal events among patients withrenal artery stenosis and systolic hypertension: rationale and design of theCORAL trial. Am Heart J. 2006;152:59–66.

. Murphy TP, Cooper CJ, Dworkin LD, et al. The Cardiovascular Out-comes with Renal Atherosclerotic Lesions (CORAL) study: rationale andmethods. J Vasc Interv Radiol. 2005;16:1295–300.

. National Institute of Neurological Disorders and Stroke Common DataElements. Available at: http://www.ninds.nih.gov/research/clinical_research/toolkit/common_data_elements.htm. Accessed June 10, 2011.

. Get With The Guidelines Stroke Program. Available at: http://www.heart.org/HEARTORG/HealthcareProfessional/GetWithTheGuidelinesHFStroke/GetWithTheGuidelinesStrokeHomePage/Get-With-The-Guidelines-Stroke-Home-Page_UCM_306098_SubHomePage.jsp.Accessed June 14, 2011.

. Centers for Medicare and Medicaid Services. Place of Service Codes forProfessional Services Database. Available at: http://www.cms.gov/manuals/downloads/clm104c26.pdf. Accessed August 11, 2011.

. Executive summary: standards of medical care in diabetes—2011. Dia-betes Care. 2011;34 Suppl 1:S4–10.

. National Heart, Lung and Blood Institute–National Cholesterol EducationProgram. Available at: http://www.nhlbi.nih.gov/guidelines/cholesterol/
index.htm. Accessed August 11, 2011.
. Centers for Medicare & Medicaid Services. Health Information Technol-ogy for Economic and Clinical Health Act–Electronic Health RecordIncentive Program; Final Rule. 2010. Available at: http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf Accessed August 11, 2011.

. Easton JD, Saver JL, Albers GW, et al. Definition and evaluation oftransient ischemic attack: a scientific statement for healthcare profession-als from the American Heart Association/American Stroke AssociationStroke Council; Council on Cardiovascular Surgery and Anesthesia;Council on Cardiovascular Radiology and Intervention; Council onCardiovascular Nursing; and the Interdisciplinary Council on PeripheralVascular Disease. Stroke. 2009;40:2276–93.

. Adams HP Jr, Bendixen BH, Kappelle LJ, et al. Classification of subtypeof acute ischemic stroke: definitions for use in a multicenter clinical trial.Stroke. 1993;24:35–41.

. Kolominsky-Rabas PL, Weber M, Gefeller O, et al. Epidemiology ofischemic stroke subtypes according to TOAST criteria: incidence, recur-rence, and long-term survival in ischemic stroke subtypes: a population-based study. Stroke. 2001;32:2735–40.

. Dolgin M. Nomenclature and Criteria for Diagnosis of Diseases of the Heartand Great Vessels. 9th ed. Boston, MA: Little, Brown & Co; 1994.

. K/DOQI clinical practice guidelines for chronic kidney disease: evalua-tion, classification, and stratification. Am J Kidney Dis. 2002;39:S1–266.

. Collins R, Burch J, Cranny G, et al. Duplex ultrasonography, magneticresonance angiography, and computed tomography angiography fordiagnosis and assessment of symptomatic, lower limb peripheral arterialdisease: systematic review. BMJ. 2007;334:1257. Abstract.

. Olin JW, Piedmonte MR, Young JR, et al. The utility of duplexultrasound scanning of the renal arteries for diagnosing significant renalartery stenosis. Ann Intern Med. 1995;122:833–8.

. Ferguson GG, Eliasziw M, Barr HW, et al. The North AmericanSymptomatic Carotid Endarterectomy Trial: surgical results in 1415patients. Stroke. 1999;30:1751–8.

. Maniglia AJ, Han DP. Cranial nerve injuries following carotid endarter-ectomy: an analysis of 336 procedures. Head Neck. 1991;13:121–4.

EY WORDS: ACCF/AHA Data Standards � clinical outcomes �

ripheral atherosclerotic vascular disease � registries.

http://www.ncdr.com/webncdr/common/

http://www.ncdr.com/webncdr/common/

http://www.ninds.nih.gov/research/clinical_research/toolkit/common_data_elements.htm

http://www.ninds.nih.gov/research/clinical_research/toolkit/common_data_elements.htm

http://www.heart.org/HEARTORG/HealthcareProfessional/GetWithTheGuidelinesHFStroke/GetWithTheGuidelinesStrokeHomePage/Get-With-The-Guidelines-Stroke-Home-Page_UCM_306098_SubHomePage.jsp




http://www.cms.gov/manuals/downloads/clm104c26.pdf

http://www.cms.gov/manuals/downloads/clm104c26.pdf

http://www.nhlbi.nih.gov/guidelines/cholesterol/index.htm

http://www.nhlbi.nih.gov/guidelines/cholesterol/index.htm

http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf

http://edocket.access.gpo.gov/2010/pdf/2010-17207.pdf

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ppendix 1. Author Relationships With Industry and Other Entities—2012 ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVSy Data Elements and Definitions for Peripheral Atherosclerotic Vascular Disease

me Employment Consultant Speaker’s Bureau

Ownership/Partnership/

Principal ResearchInstitutional, Organizational,or Other Financial Benefit Expert Witness

rk A. Creager,air

Brigham & Women’sHospital—Director, Vascular

Center

● AstraZeneca● Biomarin● Genzyme● Roche● Merck● Vascutek

None None ● Merck● Sanofi-aventis

● American Board ofVascular Medicine

● Vascular DiseaseFoundation

None

chael Belkin Brigham & Women’sHospital—Chief of Vascularand Endovascular Surgery

None None None None None None

ward I. Bluth Ochsner Clinic Foundation None None None None None None

nald E.sey, Jr

Atlantic Health—VP, Qualityand Chief Medical Officer


emantaturvedi

Wayne State University—Director, Stroke Program

● Merck ● Boehringer-Ingelheim

● BMS/SanofiPharmaceuticals

None None None None

chael D. Dake Stanford University Schoolof Medicine—Professor,

Department ofCardiothoracic Surgery

None ● Abbott Vascular● Angiodynamics● Boehringer-

Ingelheim● Cook● Cordis Endovascular● ev3● Medtronic● WL Gore

None None None None

rome L. Fleg NHLBI, Division ofEpidemiology and Clinical

Applications—MedicalOfficer

None None ● Bristol-MyersSquibb

● General Electric

None None None

n T. Hirsch University of MinnesotaMedical School—Director,Vascular Medicine Program

● ev3● Cytokinetics● Talecris

None None ● AbbottVascular*

● BMS/SanofiPharmaceuticals*

● Sanofi-aventis*● Summit

Doppler

● AHA Scientific Counciland EducationalCommittee (leadershiprole)

● Vascular DiseaseFoundation

None

chael R. Jaff Massachusetts GeneralHospital—Director, Vascular

Center

● Abbott Vascular● Access Closure● Arsenal Medical● Atheromed● Baxter Cell

Therapies● Becker Venture

Services Group*● Boston Scientific● Harvard Clinical

Research Institute● IC Sciences● Medtronic

Vascular● Micell● Nexeon Medical

Systems● Sadra Medical● Vascular

Therapies

None ● Hotspur● Icon

Interventional● Primacea

None ● VIVA Physicians’ Group ● 2009—Representeddefendant—stroke andcarotid arterydisease

hn A. Kern University of Virginia HealthSystems—Cardiothoracic

Surgeon


vid J. Malenka Dartmouth HitchcockMedical Center, Section ofCardiology—Professor of

Medicine

None None None ● AbbottVascular*

● St. JudeMedicalFoundation*

None None

ward T. Martin Oklahoma Heart Institute—Director, Cardiovascular

MRI

● Astellas Pharma● Siemens

None None ● Siemens None None

(Continued)

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ppendix 1. Continued

me Employment Consultant Speaker’s Bureau


Principal ResearchInstitutional, Organizational,or Other Financial Benefit Expert Witness

ile R.hler III

University of PennsylvaniaHealth System—Professor

of Medicine

● AMAGPharmaceuticals

● GlaxoSmithKline

● BMS/SanofiPharmaceuticals

● Merck

None ● BMS/SanofiPharmaceuticals*

● GlaxoSmithKline*

NIH* None

othy Murphy Rhode Island Hospital,Department of Diagnostic

Imaging—Medical Director,Vascular Disease Research

Center

● Bristol-MyersSquibb

● GlaxoSmithKline

None None ● AbbottVascular*

● BostonScientific*

● Cordis/Johnson& Johnson*

● OtsukaPharmaceuticals*

None None

ffrey W. Olin Mt. Sinai School ofMedicine—Director,Vascular Medicine

● FibromuscularDysplasia Societyof America

● Genzyme

None None ● Merck● BMS/Sanofi

Pharmaceuticals

● Colorado PreventionCenter

● 2009—Representeddefendant—pulmonaryembolism

dith G.gensteiner

University of ColoradoSchool of Medicine—

Director, Center forWomen’s Health Research

None ● BMS/SanofiPharmaceuticals

None None None None

bert H.ssenwasser

Thomas JeffersonUniversity Hospital forNeuroscience—Chair,

Department of NeurologicalSurgery


ter Sheehan Mt. Sinai School ofMedicine—Senior Faculty


● EdwardsLifesciences

● FoxHollow

None None None None

rry J. Stewart Johns Hopkins BayviewMedical Center—Director,Clinical/Research Exercise

Physiology

● Boston Scientific● Medifast● Milner-Fenwick

None None ● NIH* None None

neat-Jacobson

University of MinnesotaSchool of

Nursing—AssociateProfessor


None ● NHLBI* None None

bert R.church, Jr

University of Virginia—Chiefof Vascular and

Endovascular Surgery


ristopher J.ite

Ochsner Heart and VascularInstitute—Director

● Baxter None None ● BostonScientific

● Neovasc● St. Jude

● NCDR-Care Registry● SCAI

None

ck A. Ziffer Baptist Hospital SouthFlorida—Corporate Vice

President, PhysicianEnterprises. RadiologyAssociates of South

Florida—President and CEO

● Lantheus None ● SpectrumDynamics

None None None

This table represents the relationships of committee members with industry and other entities that were reported by authors to be relevant to this document. Theselationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process.e table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interestpresents ownership of �5% of the voting stock or share of the business entity, or ownership of �$10,000 of the fair market value of the business entity; or ifnds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest ifis less than significant under the preceding definition. Relationships in this table are modest unless otherwise noted.*Significant relationship.AHA indicates American Heart Association; NCDR, National Cardiovascular Data Registry; NIH, National Institutes of Health; NHLBI, National Heart, Lung, and Blood

stitute; and SCAI, Society for Cardiovascular Angiography and Interventions.

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ppendix 2. Peer Reviewer Relationships With Industry and Other Entities—2012 ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVSy Data Elements and Definitions for Peripheral Atherosclerotic Vascular Disease

Reviewer Representation ConsultantSpeaker’s

Bureau


Principal Research

Institutional,Organizational, or Other

Financial Benefit Expert Witness

vid R. Holmes, Jr ACCF—BOT None None None None ● Technology licensedfrom Mayo Clinic toAtritech

None

hard Kovacs ACCF—BOG ● BiomedicalSystems

● Cook● ECG Scanning

Services● Eli Lilly● Essentialis● Intercept● Xenoport

None None None None None

lliam Hiatt AHA Lead Reviewer None None None ● Aastrom● Aldagen● BMS/Sanofi

Pharmaceuticals● Cytokinetics● GlaxoSmithKline● Theravasc● Vermillion

None None

c E. Smith Task Force Lead Reviewer None None None ● Canadian Institutes forHealth Research Grants

● Canadian StrokeNetwork

● Hotchkiss Brain Institute● NIH

● AHA None

ardo Cury Official Reviewer—SCCT ● Astellas Pharma● GE Healthcare

None None ● Astellas Pharma● GE Healthcare● Pfizer

● SCCT None

ng-Wei Chi Official Reviewer—SVM None None None None None None

mes Galloway Official Reviewer—ADA None None None None None None

rry Goldstone Official Reviewer—VDF None None None None None None

hn A. Kaufman Official Reviewer—ACR None None None None None None

rjorie King Official Reviewer—AACVPR ● Healthways None None None None None

brah Kohlman-goboff

Official Reviewer—SVN None None None None None None

njoy Kundu Official Reviewer—SIR None None None None None None

seppe Lanzino Official Reviewer—AANS None None None None None None

ott Mitchell Official Reviewer—STS None None None None None None

rtin Prince Official Reviewer—SCMR None None None None None None

ne M. Reid Official Reviewer—NHLBI None None None None None None

bert Schainfeld Official Reviewer—SCAI None None None None None None

seph R. Schneider Official Reviewer—SVS None None None None None None

en Taylor Official Reviewer—SAIP ● Abbott None None ● Resverlogix ● CBCCT● SCCT● SAIP

None

ndal J. Thomas Official Reviewer—ACP None None None None None None

ffrey L. Anderson Content Reviewer None None None ● Toshiba ● Academic ResearchGroup

● Astra-Zeneca● Deseret Foundation● Harvard University● NIH

● 2010—Representeddefendant; strokeafter ablation foratrial fibrillation

ne Branks Content Reviewer None None None None None None

ather Gornik Content Reviewer None None ● ZinMedical

● Zin Medical ● AHA● Fibromuscular

Dysplasia Society ofAmerica

● Summit DopplerSystems

● SVM● VDF

None

e Green Content Reviewer None None None None None None

drew J. Ringer Content Reviewer None None None None None None

(Continued)

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ppendix 2. Continued

Reviewer Representation ConsultantSpeaker’s

Bureau


Principal Research

Institutional,Organizational, or Other

Financial Benefit Expert Witness

Smolderen Content Reviewer None None None None None None

rah A. Spinler Content Reviewer None None None None None None

This table represents the relevant relationships with industry and other entities that were disclosed by reviewers at the time of peer review. It does not necessarilyflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of5% of the voting stock or share of the business entity, or ownership of �$10,000 of the fair market value of the business entity; or if funds received by the personm the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it is less than significant under

e preceding definition. Relationships in this table are modest unless otherwise noted. Names are listed in alphabetical order within each category of review.rticipation in the peer review process does not imply endorsement of this document.*Significant relationship.AACVPR indicates American Association of Cardiovascular and Pulmonary Rehabilitation; ACCF—BOG, American College of Cardiology Foundation—Board ofvernors; ACCF—BOT, American College of Cardiology Foundation—Board of Trustees; ACP, American College of Physicians; ACR, American College of Radiology;A, American Diabetes Association; AHA, American Heart Association; AANS, American Association of Neurological Surgeons; CBCCT, Certification Board ofrdiovascular Computed Tomography; NIH, National Institutes of Health; NHLBI, National Heart, Lung, and Blood Institute; SAIP, Society of Atherosclerosis Imagingd Prevention; SCAI, Society for Cardiovascular Angiography and Interventions; SCCT, Society for Cardiovascular Computed Tomography; SCMR, Society forrdiovascular Magnetic Resonance; SIR, Society of Interventional Radiology; STS, Society of Thoracic Surgeons; SVM, Society of Vascular Medicine; SVN, Society
Vascular Nursing; SVS, Society of Vascular Surgery; and VDF, Vascular Disease Foundation.